Native valve repair devices and procedures

ABSTRACT

A system for implanting a repair device onto a native valve of a natural heart to repair the native valve of a patient during a non-open-heart procedure. The system includes a base assembly having a plurality of pivoting links, a pair of paddles attached to the base assembly, a pair of gripping members attached to the base assembly, and at least one coaptation or spacer element disposed between the pair of gripping members. Movement of the pivoting links of the base assembly causes the paddles to move between an open position and a closed position. The paddles and the gripping members are configured to attach to valve leaflets of the patient. The coaptation or spacer element is configured to fill at least a portion of a gap between the valve leaflets of the patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/865,904, filed Jan. 9, 2018, the contents of which is incorporatedherein in its entirety.

FIELD OF THE INVENTION

The present application relates generally to prosthetic devices andrelated methods for helping to seal native heart valves and prevent orreduce regurgitation therethrough, as well as devices and relatedmethods for implanting such prosthetic devices.

BACKGROUND OF THE INVENTION

The native heart valves (i.e., the aortic, pulmonary, tricuspid, andmitral valves) serve critical functions in assuring the forward flow ofan adequate supply of blood through the cardiovascular system. Theseheart valves can be damaged, and thus rendered less effective, bycongenital malformations, inflammatory processes, infectious conditions,or disease. Such damage to the valves can result in seriouscardiovascular compromise or death. For many years the definitivetreatment for such damaged valves was surgical repair or replacement ofthe valve during open heart surgery. However, open heart surgeries arehighly invasive and are prone to many complications. Therefore, elderlyand frail patients with defective heart valves often went untreated.More recently, transvascular techniques have been developed forintroducing and implanting prosthetic devices in a manner that is muchless invasive than open heart surgery. One particular transvasculartechnique that is used for accessing the native mitral and aortic valvesis the trans-septal technique. The trans septal technique comprisesinserting a catheter into the right femoral vein, up the inferior venacava and into the right atrium. The septum is then punctured and thecatheter passed into the left atrium.

A healthy heart has a generally conical shape that tapers to a lowerapex. The heart is four-chambered and comprises the left atrium, rightatrium, left ventricle, and right ventricle. The left and right sides ofthe heart are separated by a wall generally referred to as the septum.The native mitral valve of the human heart connects the left atrium tothe left ventricle. The mitral valve has a very different anatomy thanother native heart valves. The mitral valve includes an annulus portion,which is an annular portion of the native valve tissue surrounding themitral valve orifice, and a pair of cusps, or leaflets, extendingdownward from the annulus into the left ventricle. The mitral valveannulus can form a “D”-shaped, oval, or otherwise out-of-roundcross-sectional shape having major and minor axes. The anterior leafletcan be larger than the posterior leaflet, forming a generally “C”-shapedboundary between the abutting free edges of the leaflets when they areclosed together.

When operating properly, the anterior leaflet and the posterior leafletfunction together as a one-way valve to allow blood to flow only fromthe left atrium to the left ventricle. The left atrium receivesoxygenated blood from the pulmonary veins. When the muscles of the leftatrium contract and the left ventricle dilates (also referred to as“ventricular diastole” or “diastole”), the oxygenated blood that iscollected in the left atrium flows into the left ventricle. When themuscles of the left atrium relax and the muscles of the left ventriclecontract (also referred to as “ventricular systole” or “systole”), theincreased blood pressure in the left ventricle urges the two leafletstogether, thereby closing the one-way mitral valve so that blood cannotflow back to the left atrium and is instead expelled out of the leftventricle through the aortic valve. To prevent the two leaflets fromprolapsing under pressure and folding back through the mitral annulustoward the left atrium, a plurality of fibrous cords called chordaetendineae tether the leaflets to papillary muscles in the leftventricle.

Mitral regurgitation occurs when the native mitral valve fails to closeproperly and blood flows into the left atrium from the left ventricleduring the systolic phase of heart contraction. Mitral regurgitation isthe most common form of valvular heart disease. Mitral regurgitation hasdifferent causes, such as leaflet prolapse, dysfunctional papillarymuscles and/or stretching of the mitral valve annulus resulting fromdilation of the left ventricle. Mitral regurgitation at a centralportion of the leaflets can be referred to as central jet mitralregurgitation and mitral regurgitation nearer to one commissure (i.e.,location where the leaflets meet) of the leaflets can be referred to aseccentric jet mitral regurgitation. For central jet regurgitation, theedges of the leaflets do not meet in the middle. Therefore, the valvedoes not close and regurgitation is present.

Some prior techniques for treating mitral regurgitation in patientsinclude surgically stitching the edges of the native mitral valveleaflets directly to one another. A catheter delivered clip has beenused to attempt to clip the edges of the leaflets together like thesurgical stitching method. However, this clip has shortcomings, since itcan only be used to clip the middle edges of the leaflets where theyoverlap by 2 mm or more. Alternately, it has been attempted to usemultiple clips on the commisures of the mitral valve, where there may bemore overlap. This results in a longer operation time and the patient'sleaflets are joined at the sides, restricting blood flow. Both thesurgical and clip treatments are thought to create stress on patientleaflets.

Despite these prior techniques, there is a continuing need for improveddevices and methods for treating mitral valve regurgitation.

SUMMARY

An exemplary valve repair device for repairing a native valve of apatient includes a base assembly having a plurality of pivoting links, apair of paddles attached to the base assembly, a pair of grippingmembers attached to the base assembly, and at least one coaptation orspacer element disposed between the pair of gripping members. Movementof the pivoting links of the base assembly causes the paddles to movebetween an open position and a closed position. The paddles and thegripping members are configured to attach to valve leaflets of thepatient. The coaptation or spacer element is configured to fill a gapbetween the valve leaflets of the patient.

An exemplary valve repair system for repairing a native valve of apatient during a non-open-heart procedure includes a delivery device anda valve repair device. The delivery device has at least one lumen. Thevalve repair device is configured to be delivered through the lumen ofthe delivery device and to be attached to a native valve of a patient.The valve repair device includes a base assembly having a plurality ofpivoting links, a pair of paddles attached to the base assembly, a pairof gripping members attached to the base assembly, and at least onecoaptation or spacer element disposed between the pair of grippingmembers. Movement of the pivoting links of the base assembly causes thepaddles to move between an open position and a closed position. Thepaddles and the gripping members are configured to attach to valveleaflets of the patient. The coaptation or spacer element is configuredto fill a gap between the valve leaflets of the patient.

A further understanding of the nature and advantages of the presentinvention are set forth in the following description and claims,particularly when considered in conjunction with the accompanyingdrawings in which like parts bear like reference numerals.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify various aspects of embodiments of the presentdisclosure, a more particular description of the certain embodimentswill be made by reference to various aspects of the appended drawings.It is appreciated that these drawings depict only typical embodiments ofthe present disclosure and are therefore not to be considered limitingof the scope of the disclosure. Moreover, while the figures can be drawnto scale for some embodiments, the figures are not necessarily drawn toscale for all embodiments. Embodiments of the present disclosure will bedescribed and explained with additional specificity and detail throughthe use of the accompanying drawings.

FIG. 1 illustrates a cutaway view of the human heart in a diastolicphase;

FIG. 2 illustrates a cutaway view of the human heart in a systolicphase;

FIG. 3 illustrates a healthy mitral valve with the leaflets closed asviewed from an atrial side of the mitral valve;

FIG. 4 illustrates a dysfunctional mitral valve with a visible gapbetween the leaflets as viewed from an atrial side of the mitral valve;

FIG. 4A illustrates tricuspid valve viewed from an atrial side of thetricuspid valve;

FIG. 5 illustrates a cutaway view of the human heart in a diastolicphase, in which the chordae tendineae are shown attaching the leafletsof the mitral and tricuspid valves to ventricle walls;

FIG. 6 illustrates a valve repair device with paddles in an openposition;

FIG. 7 illustrates the valve repair device of FIG. 6, in which thepaddles are in the open position and gripping members are moved tocreate a wider gap between the gripping members and paddles;

FIG. 8 illustrates the valve repair device of FIG. 6, in which the valverepair device is in the position shown in FIG. 7 with valve tissueplaced between the gripping members and the paddles;

FIG. 9 illustrates the valve repair device of FIG. 6, in which thegripping members are moved to lessen the gap between the grippingmembers and the paddles;

FIGS. 10A-10B illustrate the movement of the paddles of the valve repairdevice of FIG. 6 from the open position to a closed position;

FIG. 11 illustrates the valve repair device of FIG. 6 in a closedposition, in which the gripping members are engaging valve tissue;

FIG. 12 illustrates the valve repair device of FIG. 6 after beingdisconnected from a delivery device and attached to valve tissue, inwhich the valve repair device is in a closed and locked condition;

FIG. 13A illustrates an exemplary embodiment of a valve repair deviceattached to the anterior leaflet and the posterior leaflet of apatient's mitral valve, shown from the left atrium of the patient'sheart with the valve repair device and leaflet tissue on the ventricularside shown in hidden lines;

FIG. 13B is an enlarged version of FIG. 13A;

FIG. 14A is another exemplary embodiment of a valve repair deviceattached to the anterior leaflet and the posterior leaflet of apatient's mitral valve with the valve repair device and leaflet tissueon the ventricular side shown in hidden lines;

FIG. 14B is another exemplary embodiment of a valve repair deviceattached to the anterior leaflet and the posterior leaflet of apatient's mitral valve, in which the valve repair device includespaddles that flex to place less stress on the mitral valve tissue withthe valve repair device and leaflet tissue on the ventricular side shownin hidden lines;

FIGS. 15A-15B illustrate another exemplary embodiment of a valve repairdevice, in which the valve repair device includes paddles that flexalong their length to place less stress on valve tissue when the valverepair device is attached to the valve tissue;

FIGS. 16A-16F illustrate another exemplary embodiment of a valve repairdevice, in which the valve repair device includes compressible paddlesthat comprise an exemplary embodiment of a wire loop;

FIGS. 16G-16H illustrate another exemplary embodiment of a valve repairdevice, in which the valve repair device includes compressible paddlesthat comprise another exemplary embodiment of a wire loop;

FIGS. 16I-16J illustrate another exemplary embodiment of a valve repairdevice, in which the valve repair device includes compressible paddlesthat comprise another exemplary embodiment of a wire loop;

FIGS. 17A-17F illustrate another exemplary embodiment of a valve repairdevice, in which the valve repair device includes compressible paddleshaving a horseshoe shape;

FIGS. 18A-18D illustrate another exemplary embodiment of a valve repairdevice, in which the valve repair device includes compressible paddleshaving a horseshoe shape;

FIGS. 18E and 18F illustrate a compressible paddle that is similar tothe compressible paddle shown in FIGS. 18C and 18D, except legs of thepaddle do not cross when the paddle is loaded into a catheter;

FIGS. 19A-19D illustrate another exemplary embodiment of a valve repairdevice, in which the valve repair device includes compressible meshpaddles;

FIGS. 20A-20B illustrate an exemplary embodiment of a paddle for a valverepair device, in which the paddle is compressible;

FIGS. 21A-21B illustrate another exemplary embodiment of a valve repairdevice, in which the paddles of the valve repair device are extendable;

FIG. 22 illustrates another exemplary embodiment of a valve repairassembly where a gripper control mechanism is configured to control eachgripper member of a valve repair device independently;

FIGS. 22A-22D illustrate another exemplary embodiment of a valve repairassembly where an exemplary embodiment of gripper control mechanism isconfigured to control four gripper members of an exemplary embodiment ofvalve repair device independently of each other;

FIG. 23 illustrates another exemplary embodiment of a valve repairassembly where a gripper control mechanism is configured to control eachgripper member of a valve repair device independently;

FIG. 24 illustrates an exemplary embodiment of a connection between aplacement shaft and a paddle control mechanism shaft of the valve repairdevice of FIG. 23, in which the gripper control mechanism is attached tothe valve repair device at the connection between the placement shaftand the paddle control mechanism shaft;

FIGS. 24A-24B illustrate an exemplary embodiment of a connection betweena placement shaft and a paddle control mechanism shaft of the valverepair device of FIG. 23, in which the gripper control mechanism isattached to the valve repair device at the connection between theplacement shaft and the shaft of the valve repair device.

FIG. 25 illustrates another exemplary embodiment of a valve repairassembly in which a gripper control mechanism is configured to controleach gripper member of a valve repair device independently of eachother;

FIG. 25A illustrates another exemplary embodiment of a gripper controlmechanism that is configured to control each gripper member of a valverepair device independently of each other;

FIG. 26 illustrates another exemplary embodiment of a valve repairassembly in which a gripper control mechanism is configured to controleach gripper member of a valve repair device independently of eachother;

FIGS. 27A-27C illustrate another exemplary embodiment of a valve repairdevice where each paddle of the valve repair device can be independentlymoved from an open position to a closed position;

FIGS. 28A-28F illustrate another exemplary embodiment of a valve repairdevice where each paddle of the valve repair device can be independentlymoved from an open position to a closed position;

FIGS. 29A-29B illustrate another exemplary embodiment of a valve repairdevice where each paddle of the valve repair device can be independentlymoved from an open position to a closed position independent of eachother;

FIG. 30 illustrates a mitral valve having a wide gap between theposterior leaflet and the anterior leaflet;

FIGS. 31A-31B illustrate another exemplary embodiment of a valve repairdevice, in which the paddles of the valve repair device expand to createa wide gap for receiving valve tissue;

FIGS. 32A-32C illustrate another exemplary embodiment of a valve repairdevice, in which the valve repair device is configured such that paddlesof the valve repair device expand by pivoting and spreading apart tocreate a wide gap for receiving valve tissue;

FIGS. 33A-33C illustrate another exemplary embodiment of a valve repairdevice, in which the valve repair device is configured such that paddlesof the valve repair device expand by spreading apart and pivoting tocreate a wide gap for receiving valve tissue;

FIGS. 34A-34B illustrate another exemplary embodiment of a valve repairdevice, in which a “W”-shaped mechanism expands the paddles of the valverepair device to create a wide gap;

FIGS. 34C-34D illustrate another exemplary embodiment of a valve repairdevice, in which a “W”-shaped mechanism expands the paddles of the valverepair device to create a wide gap;

FIGS. 35A-35B illustrate another exemplary embodiment of a valve repairdevice, in which a “W”-shaped mechanism expands paddles of the valverepair device to create a wide gap for receiving valve tissue;

FIGS. 36A-36B illustrate another exemplary embodiment of a valve repairdevice, in which a “W”-shaped mechanism expands paddles of the valverepair device to create a wide gap;

FIG. 36C illustrate an exemplary embodiment of a paddle controlmechanism for the valve repair device of FIGS. 36A-36B;

FIGS. 36D-36E illustrate another exemplary embodiment of a valve repairdevice, in which a “W”-shaped mechanism expands paddles of the valverepair device to create a wide gap;

FIGS. 37A-37D illustrate another exemplary embodiment of a valve repairdevice with mesh paddles and an internal cam for spreading the meshpaddles apart to create a wide gap for spaced apart valve tissues;

FIGS. 37E-37F illustrate another exemplary embodiment of a valve repairdevice with mesh paddles and an internal cam for spreading the meshpaddles apart to create a wide gap for spaced apart valve tissues;

FIG. 38 illustrates an exemplary embodiment of a valve repair devicethat includes an exemplary embodiment of a spacer element, in which thevalve repair device is attached to a mitral valve;

FIG. 39 illustrates another exemplary embodiment of a valve repairdevice that includes an exemplary embodiment of a spacer element, and inwhich the valve repair device is attached to a mitral valve;

FIGS. 40A-40B illustrate another exemplary embodiment of a valve repairdevice that includes an exemplary embodiment of a spacer element, inwhich the spacer element is attached to a shaft of the valve repairdevice;

FIGS. 41A-41D illustrate another exemplary embodiment of a valve repairdevice that includes an exemplary embodiment of a spacer element with afirst portion attached to a first gripping member of the valve repairdevice and a second portion attached to a second gripping member of thevalve repair device;

FIGS. 42A-42C illustrate the valve repair device of FIGS. 40A-40B withthe spacer element having various shapes;

FIGS. 43A-43C illustrate the valve repair device of FIGS. 41A-41B withthe spacer element having various shapes;

FIGS. 44A-44B illustrate another exemplary embodiment of a valve repairdevice with paddles that spread wider and an expanding spacer element;

FIGS. 45A-45C illustrate another exemplary embodiment of a valve repairdevice with an increased bailout angle for removing the valve repairdevice;

FIGS. 46A-46D illustrate another exemplary embodiment of a valve repairdevice with an increased bailout angle for removing the valve repairdevice;

FIGS. 47A-47B illustrate another exemplary embodiment of a valve repairdevice with an attachment member for connecting the paddles to thegrippers when the valve repair device is in a closed position;

FIG. 48 illustrates another exemplary embodiment of a valve repairdevice having a spring member that is configured to bias the paddles ofthe valve repair device to a closed position;

FIG. 49 illustrates another exemplary embodiment of a valve repairdevice having a threaded mechanism for moving the valve repair devicebetween the open position and the closed position;

FIG. 50 illustrates another exemplary embodiment of a valve repairdevice having gripping members attached to the paddles;

FIG. 51 illustrates another exemplary embodiment of a valve repairdevice having gripping members with a single row of barbs;

FIGS. 51A-51E illustrate another exemplary embodiment of a valve repairsystem having a valve repair assembly with a valve repair device havinggripping members configured to place a tensioning force on valve tissuewhen the valve repair device is attached to the valve tissue;

FIGS. 51F-51H illustrate another exemplary embodiment of a valve repairassembly having gripping members configured to place a tensioning forceon valve tissue when the valve repair device is attached to the valvetissue;

FIG. 52 illustrates another exemplary embodiment of a valve repairdevice having gripping members that are extendable in length;

FIGS. 53A-53B illustrate another exemplary embodiment of a valve repairdevice having gripping members that are flexible; and

FIG. 54 illustrate another exemplary embodiment of a valve repairdevice, in which gripping members are attached to a separate springmember.

DETAILED DESCRIPTION

The following description refers to the accompanying drawings, whichillustrate specific embodiments of the invention. Other embodimentshaving different structures and operation do not depart from the scopeof the present invention.

Exemplary embodiments of the present disclosure are directed to devicesand methods for repairing a defective heart valve. It should be notedthat various embodiments of native valve reparation devices and systemsfor delivery are disclosed herein, and any combination of these optionscan be made unless specifically excluded. In other words, individualcomponents of the disclosed devices and systems can be combined unlessmutually exclusive or otherwise physically impossible.

FIGS. 1 and 2 are cutaway views of the human heart H in diastolic andsystolic phases, respectively. The right ventricle RV and left ventricleLV are separated from the right atrium RA and left atrium LA,respectively, by the tricuspid valve TV and mitral valve MV; i.e., theatrioventricular valves. Additionally, the aortic valve AV separates theleft ventricle LV from the ascending aorta AA, and the pulmonary valvePV separates the right ventricle from the pulmonary artery PA. Each ofthese valves has flexible leaflets (e.g., leaflets 302, 304 shown inFIGS. 3 and 4) extending inward across the respective orifices that cometogether or “coapt” in the flowstream to form the one-way,fluid-occluding surfaces. The native valve repair systems of the presentapplication are described primarily with respect to the mitral valve MV.Therefore, anatomical structures of the left atrium LA and Leftventricle LV will be explained in greater detail. It should beunderstood that the devices described herein may also be used inrepairing other native valves, e.g., the devices can be used inrepairing the tricuspid valve TV, the aortic valve AV, and the pulmonaryvalve PV.

The left atrium LA receives oxygenated blood from the lungs. During thediastolic phase, or diastole, seen in FIG. 1, the blood that waspreviously collected in the left atrium LA (during the systolic phase)moves through the mitral valve MV and into the left ventricle LV byexpansion of the left ventricle LV. In the systolic phase, or systole,seen in FIG. 2, the left ventricle LV contracts to force the bloodthrough the aortic valve AV and ascending aorta AA into the body. Duringsystole, the leaflets of the mitral valve MV close to prevent the bloodfrom regurgitating from the left ventricle LV and back into the leftatrium LA, and blood is collected in the left atrium from the pulmonaryvein. In one exemplary embodiment, the devices described by the presentapplication are used to repair the function of a defective mitral valveMV. That is, the devices are configured to help close the leaflets ofthe mitral valve to prevent blood from regurgitating from the leftventricle LV and back into the left atrium LA.

Referring to FIGS. 1-5, the mitral valve MV includes two leaflets, theanterior leaflet 302 and the posterior leaflet 304. The mitral valve MValso includes an annulus 306, which is a variably dense fibrous ring oftissues that encircles the leaflets 302, 304. Referring to FIG. 5, themitral valve MV is anchored to the wall of the left ventricle LV bychordae tendineae 501. The chordae tendineae 501 are cord-like tendonsthat connect the papillary muscles 503 (i.e., the muscles located at thebase of the chordae tendineae and within the walls of the leftventricle) to the leaflets 302, 304 of the mitral valve MV. Thepapillary muscles serve to limit the movements of the mitral valve MVand prevent the mitral valve from being reverted. The mitral valve MVopens and closes in response to pressure changes in the left atrium LAand the left ventricle LV. The papillary muscles do not open or closethe mitral valve MV. Rather, the papillary muscles brace the mitralvalve MV against the high pressure needed to circulate blood throughoutthe body. Together the papillary muscles and the chordae tendineae areknown as the subvalvular apparatus, which functions to keep the mitralvalve MV from prolapsing into the left atrium LA when the mitral valvecloses.

Various disease processes can impair proper function of one or more ofthe native valves of the heart H. These disease processes includedegenerative processes (e.g., Barlow's Disease, fibroelasticdeficiency), inflamatory processes (e.g., Rheumatic Heart Disease), andinfectious processes (e.g., endocarditis). In addition, damage to theleft ventricle LV or the right ventricle RV from prior heart attacks(i.e., myocardial infarction secondary to coronary artery disease) orother heart diseases (e.g., cardiomyopathy) can distort a native valve'sgeometry, which can cause the native valve to dysfunction. However, thevast majority of patients undergoing valve surgery, such as surgery tothe mitral valve MV, suffer from a degenerative disease that causes amalfunction in a leaflet (e.g., leaflets 302, 304) of a native valve(e.g., the mitral valve MV), which results in prolapse andregurgitation.

Generally, a native valve may malfunction in two different ways. Onepossible malfunction is valve stenosis, which occurs when a native valvedoes not open completely and thereby causes an obstruction of bloodflow. Typically, valve stenosis results from buildup of calcifiedmaterial on the leaflets of a valve, which causes the leaflets tothicken and impairs the ability of the valve to fully open to permitforward blood flow.

Another possible malfunction is valve regurgitation, which occurs whenthe leaflets of the valve do not close completely thereby causing bloodto leak back into the prior chamber (e.g., causing blood to leak fromthe left ventricle to the left atrium). There are three mechanisms bywhich a native valve becomes regurgitant or incompetent, which includeCarpentier's type I, type II, and type III malfunctions. A Carpentiertype 1 malfunction involves the dilation of the annulus such thatnormally functioning leaflets are distracted from each other and fail toform a tight seal (i.e., do not coapt properly). Included in a type Imechanism malfunction are perforations of the leaflets, as inendocarditis. A Carpentier's type II malfunction involves prolapse ofone or more leaflets of a native valve above a plane of coaption. ACarpentier's type III malfunction involves restriction of the motion ofone or more leaflets of a native valve such that the leaflets areabnormally constrained below the plane of the annulus. Leafletrestriction can be caused by rheumatic disease (Ma) or dilation of aventricle (IIIb).

Referring to FIG. 3, when a healthy mitral valve MV is in a closedposition, the anterior leaflet 302 and the posterior leaflet 304 coapt,which prevents blood from leaking from the left ventricle LV to the leftatrium LA. Referring to FIG. 4, regurgitation occurs when the anteriorleaflet 302 and/or the posterior leaflet 304 of the mitral valve MV isdisplaced into the left atrium LA during systole. This failure to coaptcauses a gap 408 between the anterior leaflet 302 and the posteriorleaflet 304, which allows blood to flow back into the left atrium LAfrom the left ventricle LV during systole. As set forth above, there areseveral different ways that a leaflet (e.g. leaflets 302, 304 of mitralvalve MV) may malfunction, which can thereby lead to regurgitation.

Although stenosis or regurgitation can affect any valve, stenosis ispredominantly found to affect either the aortic valve AV or thepulmonary valve PV, and regurgitation is predominantly found to affecteither the mitral valve MV or the tricuspid valve TV. Both valvestenosis and valve regurgitation increase the workload of the heart Hand may lead to very serious conditions if left un-treated; such asendocarditis, congestive heart failure, permanent heart damage, cardiacarrest, and ultimately death. Because the left side of the heart (i.e.,the left atrium LA, the left ventricle LV, the mitral valve MV, and theaortic valve AV) is primarily responsible for circulating the flow ofblood throughout the body, malfunction of the mitral valve MV or theaortic valve AV is particularly problematic and often life threatening.Accordingly, because of the substantially higher pressures on the leftside of the heart, dysfunction of the mitral valve MV or the aorticvalve AV is much more problematic.

Malfunctioning native heart valves may either be repaired or replaced.Repair typically involves the preservation and correction of thepatient's native valve. Replacement typically involves replacing thepatient's native valve with a biological or mechanical substitute.Typically, the aortic valve AV and pulmonary valve PV are more prone tostenosis. Because stenotic damage sustained by the leaflets isirreversible, the most conventional treatments for a stenotic aorticvalve or stenotic pulmonary valve are removal and replacement of thevalve with a surgically implanted heart valve, or displacement of thevalve with a transcatheter heart valve. The mitral valve MV and thetricuspid valve TV are more prone to deformation of leaflets, which, asdescribed above, prevents the mitral valve or tricuspid valve fromclosing properly and allows for regurgitation or back flow of blood fromthe ventricle into the atrium (e.g., a deformed mitral valve MV mayallow for regurgitation or back flow from the left ventricle LV to theleft atrium LA). The regurgitation or back flow of blood from theventricle to the atrium results in valvular insufficiency. Deformationsin the structure or shape of the mitral valve MV or the tricuspid valveTV are often repairable. In addition, regurgitation can occur due to thechordae tendineae 501 becoming dysfunctional (e.g., the chordaetendineae may stretch or rupture), which allows the anterior leaflet 302and the posterior leaflet 304 to be reverted such that blood isregurgitated into the left atrium LA. The problems occurring due todysfunctional chordae tendineae 501 can be repaired by repairing thechordae tendineae or the structure of the mitral valve (e.g., bysecuring the leaflets 302, 304 at the affected portion of the mitralvalve).

The devices and procedures disclosed herein make reference to repairingthe structure of a mitral valve. However, it should be understood thatthe devices and concepts provided herein can be used to repair anynative valve, as well as any component of a native valve. Referring toFIG. 4A, any of the devices and concepts provided herein can be used torepair the tricuspid valve TV. For example, any of the devices andconcepts provided herein can be used between any two of the anteriorleaflet 4011, septal leaflet 4012, and posterior leaflet 4013 to preventregurgitation of blood from the right ventricle into the right atrium.In addition, any of the devices and concepts provided herein can be usedon all three of the leaflets 4011, 4012, 4013 together to preventregurgitation of blood from the right ventricle to the right atrium.That is, the valve repair devices provided herein can be centrallylocated between the three leaflets 4011, 4012, 4013.

FIGS. 6-13B illustrate a valve repair system 600 for repairing a nativevalve of a patient. The valve repair system 600 includes a deliverydevice 601 and a valve repair device 602, in which delivery device isconfigured to deliver the valve repair device to the native valve of apatient, and in which the valve repair device is configured to attach toleaflets of a native valve to repair the native valve of the patient.The delivery device 601 can take any suitable form that is capable ofdelivering the valve repair device 602 to the native valve of a patient.In certain embodiments, the valve repair system 600 is configured todeliver the valve repair device 602 to a native valve of a patientduring a non-open-heart procedure. Suitable delivery means forpercutaneously delivering the valve repair system 600 in aminimal-invasive procedure, can be delivery sleeves or deliverycatheters which may be inserted through small incisions in the skin of apatient and advanced to the implantation site, for example along anendovascular (e.g. transfemoral) path or a transapical path.

The valve repair device 602 includes a base assembly 604, a pair ofpaddles 606, and a pair of gripping members 608. In one exemplaryembodiment, the paddles 606 can be integrally formed with the baseassembly. For example, the paddles 606 can be formed as extensions oflinks of the base assembly. In the illustrated example, the baseassembly 604 of the valve repair device 602 has a shaft 603, a coupler605 configured to move along the shaft, and a lock 607 configured tolock the coupler in a stationary position on the shaft. The coupler 605is mechanically connected to the paddles 606, such that movement of thecoupler 605 along the shaft 603 causes the paddles to move between anopen position and a closed position. In this way, the coupler 605 servesas means for mechanically coupling the paddles 606 to the shaft 603 and,when moving along the shaft 603, for causing the paddles 606 to movebetween their open and closed positions. In certain embodiments, thegripping members 608 are pivotally connected to the base assembly 604(e.g., the gripping members 608 can be pivotally connected to the shaft603, or any other suitable member of the base assembly), such that thegripping members can be moved to adjust the width of the opening 614between the paddles 606 and the gripping members 608. The grippingmember 608 can include a barbed portion 609 for attaching the grippingmembers to valve tissue when the valve repair device 602 is attached tothe valve tissue. The gripping member 608 forms a means for gripping thevalve tissue (in particular tissue of the valve leaflets) with asticking means or portion such as the barbed portion 609. When thepaddles 606 are in the closed position, the paddles engage the grippingmembers 608, such that, when valve tissue is attached to the barbedportion 609 of the gripping members, the paddles act as holding orsecuring means to hold the valve tissue at the gripping members and tosecure the valve repair device 602 to the valve tissue. In someembodiments, the gripping members 608 are configured to engage thepaddles 606 such that the barbed portion 609 engages the valve tissuemember and the paddles 608 to secure the valve repair device 602 to thevalve tissue member. For example, in certain situations, it may beadvantageous to have the paddles 606 maintain an open position and havethe gripping members 608 move outward toward the paddles 606 to engage avalve tissue member and the paddles 606.

While the embodiment shown in FIGS. 6-13B illustrate a pair of paddles606 and a pair of gripping members 608, it should be understood that thevalve repair device 602 can include any suitable number of paddles andgripping members. In certain embodiments, the valve repair system 600includes a placement shaft 613 that is removably attached to the shaft603 of the base assembly 604 of the valve repair device 602. After thevalve repair device 602 is secured to valve tissue, the placement shaft613 is removed from the shaft 603 to remove the valve repair device 602from the remainder of the valve repair system 600, such that the valverepair device 602 can remain attached to the valve tissue, and thedelivery device 601 can be removed from a patient's body.

The valve repair system 600 can also include a paddle control mechanism610, a gripper control mechanism 611, and a lock control mechanism 612.The paddle control mechanism 610 is mechanically attached to the coupler605 to move the coupler along the shaft, which causes the paddles 606 tomove between the open and closed positions. The paddle control mechanism610 can take any suitable form, such as, for example, a shaft or rod.For example, the paddle control mechanism can comprise a hollow shaft, acatheter tube or a sleeve that fits over the placement shaft 613 and theshaft 603 and is connected to the coupler 605. The gripper controlmechanism 611 is configured to move the gripping members 608 such thatthe width of the opening 614 between the gripping members and thepaddles 606 can be altered. The gripper control mechanism 611 can takeany suitable form, such as, for example, a line, a suture or wire, arod, a catheter, etc.

The lock control mechanism 612 is configured to lock and unlock thelock. The lock 607 serves as locking means for locking the coupler 605in a stationary position with respect to the shaft 603 and can take awide variety of different forms and the type of lock control mechanism612 may be dictated by the type of lock used. In one embodiment, thelock 607 takes the form of locks often used in caulk guns. That is, thelock 607 includes a pivotable plate having a hole, in which the shaft603 of the valve repair device 602 is disposed within the hole of thepivotable plate. In this embodiment, when the pivotable plate is in thetilted position, the pivotable plate engages the shaft 603 to maintain aposition on the shaft 603, but, when the pivotable plate is in asubstantially non-tilted position, the pivotable plate can be movedalong the shaft (which allows the coupler 605 to move along the shaft603). In other words, the coupler 605 is prevented from moving in thedirection Y (as shown in FIG. 10A) along the shaft 603 when pivotableplate of the lock 607 is in a tilted (or locked) position, and thecoupler is allowed to move in the direction Y along the shaft 603 whenthe pivotable plate is in a substantially non-tilted (or unlocked)position. In embodiments in which the lock 607 includes a pivotableplate, the lock control mechanism 612 is configured to engage thepivotable plate to move the plate between the tilted and substantiallynon-tilted positions. The lock control mechanism 612 can be, forexample, a rod, a suture, a wire, or any other member that is capable ofmoving a pivotable plate of the lock 607 between a tilted andsubstantially non-tilted position. In certain embodiments, the pivotableplate of the lock 607 is biased in the tilted (or locked) position, andthe lock control mechanism 612 is used to move the plate from the titledposition to the substantially non-tilted (or unlocked) position. Inother embodiments, the pivotable plate of the lock 607 is biased in thesubstantially non-tilted (or unlocked) position, and the lock controlmechanism 612 is used to move the plate from the substantiallynon-tilted position to the tilted (or locked) position.

FIGS. 10A-10B illustrate the valve repair device 602 moving from an openposition (as shown in FIG. 10A) to a closed position (as shown in FIG.10B). The base assembly 604 includes a first link 1021 extending frompoint A to point B, a second link 1022 extending from point A to pointC, a third link 1023 extending from point B to point D, a fourth link1024 extending from point C to point E, and a fifth link 1025 extendingfrom point D to point E. The coupler 605 is movably attached to theshaft 603, and the shaft 603 is fixed to the fifth link 1025. The firstlink 1021 and the second link 1022 are pivotally attached to the coupler605 at point A, such that movement of the coupler 605 along the shaft603 moves the location of point A and, consequently, moves the firstlink 1021 and the second link 1022. The first link 1021 and the thirdlink 1023 are pivotally attached to each other at point B, and thesecond link 1022 and the fourth link 1024 are pivotally attached to eachother at point C. One paddle 606 a is attached to first link 1021 suchthat movement of first link 1021 causes the paddle 606 a to move, andthe other paddle 606 b is attached to the second link 1022 such thatmovement of the second link 1022 causes the paddle 606 b to move.Alternatively, the paddles 606 a, 606 b can be connected to links 1023,1024 or be extensions of links 1023, 1024.

In order to move the valve repair device from the open position (asshown in FIG. 10A) to the closed position (as shown in FIG. 10B), thecoupler 605 is moved along the shaft 603 in the direction Y, which movesthe pivot point A for the first links 1021 and the second link 1022 to anew position. Movement of the coupler 605 (and pivot point A) in thedirection Y causes a portion of the first link 1021 near point A to movein the direction H, and the portion of the first link 1021 near point Bto move in the direction J. The paddle 606 a is attached to the firstlink 1021 such that movement of the coupler 605 in the direction Ycauses the paddle 606 a to move in the direction Z. In addition, thethird link 1023 is pivotally attached to the first link 1021 at point Bsuch that movement of the coupler 605 in the direction Y causes thethird link 1023 to move in the direction K. Similarly, movement of thecoupler 605 (and pivot point A) in the direction Y causes a portion ofthe second link 1022 near point A to move in the direction L, and theportion of the second link 1022 near point C to move in the direction M.The paddle 606 b is attached to the second link 1022 such that movementof the coupler 605 in the direction Y causes the paddle 606 b to move inthe direction V. In addition, the fourth link 1024 is pivotally attachedto the second link 1022 at point C such that movement of the coupler 605in the direction Y causes the fourth link 1024 to move in the directionN. FIG. 10B illustrates the final position of the valve repair device602 after the coupler 605 is moved as shown in FIG. 10A.

Referring to FIG. 7, the valve repair device 602 is shown in the openposition (similar to the position shown in FIG. 10A), and the grippercontrol mechanism 611 is shown moving the gripping members 608 toprovide a wider gap at the opening 614 between the gripping members andthe paddles 606. In the illustrated embodiment, the gripper controlmechanism 611 includes a line, such as a suture, a wire, etc. that isthreaded through an opening in an end of the gripper members 608. Bothends of the line extending through the delivery opening 716 of thedelivery device 601. When the line is pulled through the deliveryopening 716 in the direction Y, the gripping members 608 move inward inthe direction X, which causes the opening 614 between the grippingmembers and the paddles 606 to become wider.

Referring to FIG. 8, the valve repair device 602 is shown such thatvalve tissue 820 is disposed in the opening 614 between the grippingmembers 608 and the paddles 606. Referring to FIG. 9, after the valvetissue 820 is disposed between the gripping members 608 and the paddles606, the gripper control mechanism 611 is used to lessen the width ofthe opening 614 between the gripping members and the paddles. That is,in the illustrated embodiment, the line of the gripper control mechanism611 is released from or pushed out of the opening 716 of the deliverymember in the direction H, which allows the gripping members 608 to movein the direction D to lessen the width of the opening 614. While thegripper control mechanism 611 is shown moving the gripping members 608to increase the width of the opening 614 between the gripping membersand the paddles 606 (FIG. 8), it should be understood that the grippingmembers may not need to be moved in order to position valve tissue inthe opening 614. In certain circumstances, however, the opening 614between the paddles 606 and the gripping members 608 may need to bewider in order to receive the valve tissue.

Referring to FIG. 11, the valve repair device 602 is in the closedposition and secured to valve tissue 820. The valve repair device 602 issecured to the valve tissue 820 by the paddles 606 a, 606 b and thegripping members 608 a, 608 b. In particular, the valve tissue 820 isattached to the valve repair device 602 by the barbed portion 609 of thegripping members 608 a, 608 b, and the paddles 606 a, 606 b engage thegripping members 608 to secure the valve repair device 602 to the valvetissue 820. In order to move the valve repair device 602 from the openposition to the closed position, the lock 607 is moved to an unlockedcondition (as shown in FIG. 11) by the lock control mechanism 612. Oncethe lock 607 is in the unlocked condition, the coupler 605 can be movedalong the shaft 603 by the paddle control mechanism 610. In theillustrated embodiment, the paddle control mechanism 610 moves thecoupler 605 in a direction Y along the shaft, which causes one paddle606 a to move in a direct X and the other paddle 606 b to move in adirection Z. The movement of the paddles 606 a, 606 b in the direction Xand the direction Z, causes the paddles to engage the gripping members608 a, 608 b and secure the valve repair device 602 to the valve tissue820.

Referring to FIG. 12, after the paddles 606 are moved to the closedposition to secure the valve repair device 602 to the valve tissue 820(as shown in FIG. 11), the lock 607 is moved to the locked condition bythe locking control mechanism 611 (FIG. 11) to maintain the valve repairdevice 602 in the closed position. After the valve repair device 602 ismaintained in the locked condition by the lock 607, the valve repairdevice 602 is removed from the delivery device 601 by disconnecting theshaft 603 from the placement shaft 613 (FIG. 11). In addition, the valverepair device 602 is disengaged from the paddle control mechanism 610(FIG. 11), the gripper control mechanism 611 (FIG. 11), and the lockcontrol mechanism 612. Removal of the valve repair device 602 from thedelivery device 601 allows the valve repair device to remain secured tovalve tissue 820 while the delivery device 601 is removed from apatient.

Referring to FIGS. 13A-13B, the mitral valve 1300 of a patient is shownwith a valve repair device 602 attached to the anterior leaflet 1301 andthe posterior leaflet 1302 of the mitral valve. FIGS. 13A-13B are viewsfrom the atrial side of the mitral valve 1300 with portions of the valverepair device 602 and captured mitral valve leaflet tissue on theventricular side of the mitral valve depicted in hidden lines. Duringthe diastolic phase (as shown in FIG. 1), the blood that collects in theleft atrium of the heart enters the mitral valve 1300 by expansion ofthe left ventricle of the heart. The anterior leaflet 1301 and theposterior leaflet 1302 open to allow blood to travel from the leftatrium to the left ventricle. In the systolic phase (as shown in FIG.2), the left ventricle contracts to force the blood through the aorticvalve and the ascending aorta and into the body. During systole, theleaflets of the mitral valve MV close to prevent the blood fromregurgitating back into the left atrium LA. As described above,regurgitation of blood from the left ventricle to the left atriumthrough the mitral valve occurs when the anterior leaflet 1301 and theposterior leaflet 1302 do not close entirely such that a gap existsbetween the anterior leaflet and the posterior leaflet. In order torepair a mitral valve 1300 to prevent regurgitation of blood through themitral valve, the valve repair device 602 is connected to the anteriorleaflet 1301 and the posterior leaflet 1302 to close the gap.

Referring to FIG. 13A, the mitral valve 1300 is shown from the leftatrium of a patient's heart (e.g., from the view indicated by line A-Ain FIG. 5). In the illustrated embodiment, the mitral valve 1300 isshown in an open position (i.e., the position the mitral valve takesduring the diastolic phase). The valve repair device 602 is attached tothe anterior leaflet 1301 and the posterior leaflet 1302 of the mitralvalve 1300 in the left ventricle of the patient's heart, and is shown indotted lines in FIGS. 13A-13B to indicate the location of the valverepair device with respect to the mitral valve. As shown in FIGS.13A-13B, the valve repair device 602 engages the anterior leaflet 1301and the posterior leaflet 1302 and causes the anterior leaflet andposterior leaflet to engage each other (i.e., the valve repair devicecloses a portion of the gap between the anterior leaflet and theposterior leaflet). The valve repair device 602 can be placed in alocation in which a gap exists between the anterior leaflet 1301 and theposterior leaflet 1302 when the mitral valve 1301 is in a closedposition (i.e., the position of the mitral valve during the systolicphase), such that the valve repair device will prevent the gap fromoccurring. The illustrated embodiment shows the mitral valve 1300 andvalve repair device 602 during the diastolic phase. That is, during thediastolic phase, the valve repair device 602 will cause a portion of themitral valve to remain closed, but the portions of the mitral valve notengaged by the valve repair device will open such that gaps 1303 arecreated to allow blood to flow from the left atrium to the leftventricle.

Referring to FIG. 13B, the valve repair device 602 is attached to boththe anterior leaflet 1301 and the posterior leaflet 1302. In particular,a portion 1301 a of the anterior leaflet 1301 is secured between apaddle 606 a and a gripping member 608 a of the valve repair device 602,and a portion 1302 b of the posterior leaflet 1302 is secured betweenanother paddle 606 b and another gripping member 608 b of the valverepair device. The valve repair device 602 is secured and locked to themitral valve 1300, for example, as shown in FIGS. 6-12.

FIGS. 14A-14B illustrate exemplary embodiments of a valve repair device602 attached to the anterior leaflet 1301 and posterior leaflet 1302 ofa mitral valve 1300. The mitral valve 1300 is shown from the left atriumof a patient's heart (e.g., from the view indicated by line A-A in FIG.5). Still referring to FIGS. 14A-14B, the valve repair device 602includes a first paddle 606 a, a second paddle 606 b, a first grippingmember 608 a, and a second gripping member 608 b. A portion 1301 a ofthe anterior leaflet 1301 is secured between the first paddle 606 a andthe first gripping member 608 a of the valve repair device 602, and aportion 1302 b of the posterior leaflet 1302 is secured between thesecond paddle 606 b and the second gripping member 608 b of the valverepair device. The first and second paddles 606 a, 606 b include a mainportion 1404 and side portions 1405. Referring to FIG. 14A, the valverepair device 602 is configured such that the portions 1301 a, 1302 b ofthe mitral valve 1300 conform to or generally conform to the shape ofthe paddles 606 a, 606 b. That is, the valve leaflet portions 1301 a,1302 b are pressed into the paddles by the gripping members 608 a, 608b, such that the valve leaflet portions 1301 a, 1301 b are disposedalong a main portion 1404 and side portions 1405 of the paddles 606 a,606 b. In the embodiment of the valve repair device 602 shown in FIG.14A, the paddles 606 a, 606 b can be made of a rigid material, forexample, steel, molded plastic, etc.

In the exemplary embodiment illustrated by FIG. 14B, the paddles 606 a,606 b of the valve repair device 602 are configured to flex. Because ofthis flex, when the valve repair device is attached to the mitral valve1300, the mitral valve tissue portions 1301 a, 1302 b move the sideportions 1405 of the paddles as indicated by arrows 1450, which reducesthe stress placed on the mitral valve by the valve repair device ascompared to the embodiment illustrated by FIG. 14A. That is, the flexingresults in a more gradual contouring of the mitral valve tissue by thepaddles, while still securely attaching the valve repair device 602 tothe mitral valve tissue. In the embodiment of the valve repair device602 shown in FIG. 14B, the paddles 606 a, 606 b can be made of a widevariety of different flexible materials or rigid materials that are cutor otherwise processed to provide flexibility.

FIGS. 15A-15B illustrate another exemplary embodiment of a valve repairdevice 602. Referring to FIG. 15A, the valve repair device 602 is in theopen position and about to engage valve tissue 820 (e.g., the leafletsof a mitral valve). Referring to FIG. 15B, the valve repair device 602is in the closed position and secured to the valve tissue 820. The valverepair device 602 can take any suitable form, such as, for example, anyform described in the present application. The valve repair device 602can be moved between the open and closed position, and be attached tothe valve tissue 820, by a valve repair system, such as, for example,any valve repair system described in the present application. In theillustrated embodiment, the valve repair device 602 includes paddles 606and gripping members 608. The gripping members 608 include a barbedportion 609 for attaching the gripping members to valve tissue 820.Referring to FIG. 15A, when the valve repair device 602 is in the openposition, the paddles 606 maintain an original form. Referring to FIG.15B, upon engagement with the valve tissue 820, the paddles 606 flexalong their length L. That is, a portion of the paddles 606 flex in aninward direction X, and another portion of the paddles extend in anoutward direction Z. This flexing of the paddles 606 allows the paddlesto conform to the shape of the valve tissue, which places less stress onthe valve tissue.

Referring to FIGS. 16A-16F, another exemplary embodiment of a valverepair device 602 includes paddles 606 having a wire loop 1601. The wireloop 1601 can be made of, for example, any suitable metal material,laser cut loops from a sheet of nitinol, a tube of nitinol, or any othersuitable material. In some embodiments, the wire loop 1601 can havevarying dimensions throughout the length of the wire loop 1601 tooptimize the paddle pinch force and the paddle crimp force on a valvetissue when paddle engages the valve tissue. For example, certainsections of the wire loop 1601 can be thinner than other sections of thewire loop 1601. In certain embodiments, the wire loop 1601 of thepaddles 606 is compressible, which allows the paddles 606 to be disposedin a delivery device 601 (e.g., a catheter) that has a small diameter(as shown in FIG. 16E) for delivery of the valve repair device 602 to anative valve of a patient, and also allows the paddles 606 to expand (asshown in FIGS. 16A-16D) upon exiting the delivery device 601 such thatthe paddles 606 have a larger surface area for engaging the native valveof the patient. The valve repair device 602 can take any suitable form,such as, for example, any form described in the present application. Thevalve repair device 602 can be moved between the open and closedposition, and be attached to a native valve, by a valve repair system,such as, for example, any valve repair system described in the presentapplication.

FIGS. 16A-16B illustrate the valve repair device 602 in the openposition, and FIGS. 16C-16D illustrate the valve repair device in theclosed position. Referring to FIGS. 16A-16B, when the valve repairdevice 602 is in the expanded and open position, the paddles 606 extendoutward to create wide opening 614 between the paddles 606 and grippingmembers 608 of the valve repair device 602. Referring to FIGS. 16C-16D,when the valve repair device 602 is in the expanded and closed position,the paddles 606 engage the gripping members 608 such that valve tissuecan be secured between the paddles and the gripping members. The paddles606 include a curved surface 1603, which is configured to place lessstress on valve tissue when the valve repair device 602 is attached tothe valve tissue. When the paddles 606 are in the expanded condition,the paddles have a width W. The width W can be, for example, betweenabout 4 mm and about 21 mm, such as, between about 5 mm and about 20 mm,such as between about 7.5 mm and about 17.5 mm, such as between about 10mm and about 15 mm. In certain embodiments, the width W can be, forexample, 5 mm or more, such as about 7.5 mm or more, such as about 10 mmor more, such as about 15 mm or more, such as about 20 mm or more. Inother embodiments, the width W can be less than 5 mm. In certainembodiments, the paddles 606 include a material 1605 disposed over thewire loop 1601 for creating a contact area for the paddles to engagevalve tissue. The material 1605 can be any suitable material, such as,for example, a woven material, an electrospun material, or any othermaterial that is capable of promoting tissue ingrowth and protectingliners of the delivery device 601 (FIG. 6) during tracking. In certainembodiments, the material 1605 can be a blood-impermeable cloth, such asa PET cloth or biocompatible covering material such as a fabric that istreated with a coating that is impermeable to blood, polyester, or aprocessed biological material, such as pericardium.

Referring to FIG. 16E, the paddles 606 are in a compressed conditionwhen the paddles are disposed in a delivery device 601. When the paddles606 are in the compressed condition, the paddles have a width H. Thewidth H can be, for example between about 4 mm and about 7 mm, such as,between about 5 mm and about 6 mm. In alternative embodiments, the widthH can be less than 4 mm or more than 7 mm. In certain embodiments, thewidth H of the compressed paddles 606 is substantially equal to a widthD of the delivery opening 716 of the delivery device 601. The ratiobetween the width W of the paddles in the expanded condition and thewidth H of the paddles in the compressed condition can be, for example,about 4 to 1 or less, such as about 3 to 1 or less, such as about 2 to 1or less, such as about 1.5 to 1, such as about 1.25 to 1, such as about1 to 1. In alternative embodiments, the ratio between the width W andthe width H can be more than 4 to 1. Referring to FIG. 16F, a paddle 606is moved from the expanded condition to the compressed condition bycompressing the paddle in the direction Y and extending a length of thepaddle in the direction X.

FIGS. 16G-16H illustrate another exemplary embodiment of a valve repairdevice 602 in the open position, in which the valve repair deviceincludes paddles 606 having a wire loop 1601. In the illustratedembodiment, the paddles 606 are shown having a wire loop 1601 thatincludes three lobes 1611. Referring to FIGS. 16I-16J, another exemplaryembodiment of a valve repair device 602 includes paddles 606 having awire loop 1601 with two lobes 1611. While the embodiments shown in FIGS.16G-16H and 16I-16J show the wire loop 1601 of the paddles 606 havingthree lobes and two lobes, respectively, it should be understood thatthe valve repair device 602 can include paddles 606 with a wire loop1601 having any suitable number of lobes 1611, such as, for example, twoor more lobes, three or more lobes, four or more lobes, five or morelobes, etc. A paddle 606 having a wire loop 1601 having lobes isadvantageous because a paddle having lobes can more easily allow chordaetendinae to assume their natural positions than a single wire loophaving no lobes. That is, the chordae tendinae can move into spacesbetween the multiple of loops.

The embodiments of the valve repair devices 602 shown in FIGS. 16G-16Hand 16I-16J can include any of the features described above withreference to FIGS. 16A-16F. For example, the embodiments of the valverepair devices 602 shown in FIGS. 16G-16H and 16I-16J can include awidth W, in which the width W can be, for example, between about 4 mmand about 21 mm, such as, between about 5 mm and about 20 mm, such asbetween about 7.5 mm and about 17.5 mm, such as between about 10 mm andabout 15 mm. In certain embodiments, the width W can be, for example, 5mm or more, such as about 7.5 mm or more, such as about 10 mm or more,such as about 15 mm or more, such as about 20 mm or more. In otherembodiments, the width W can be less than 5 mm. The embodiments for thepaddles 606 shown in FIGS. 16G-16H and 16I-16J can also include amaterial disposed over the wire loop 1601 for creating a contact areafor the paddles to engage valve tissue. The material can be any suitablematerial, such as, for example, a woven material, an electrospunmaterial, or any other suitable material that is capable of promotingtissue ingrowth and protecting liners of the delivery device 601 (FIG.6) during tracking. In certain embodiments, the material 1605 can be ablood-impermeable cloth, such as a PET cloth or biocompatible coveringmaterial such as a fabric that is treated with a coating that isimpermeable to blood, polyester, or a processed biological material,such as pericardium. The embodiments for the paddles 606 shown in FIGS.16G-16H and 16I-16J can also be compressed when disposed in a deliverydevice 601 (e.g., just as shown in FIG. 16E with respect to theembodiment of the paddles 606 shown in FIGS. 16A-16B). The ratio betweenthe width W of the paddles 606 in the expanded condition and the widthof the paddles in the compressed condition can be, for example, about 4to 1 or less, such as about 3 to 1 or less, such as about 2 to 1 orless, such as about 1.5 to 1, such as about 1.25 to 1, such as about 1to 1. In alternative embodiments, the ratio between the width W and thewidth H can be more than 4 to 1.

Referring to FIGS. 17A-17F, another exemplary embodiment of a valverepair device 602 includes paddles 606 having a horseshoe shape 1701. Incertain embodiments, the horseshoe shape 1701 of the paddles 606 iscompressible, which allows the paddles 606 to be disposed in a deliverydevice 601 (e.g., a catheter) that has a small diameter (as shown inFIG. 17F) for delivery of the valve repair device 602 to a native valveof a patient, and also allows the paddles 606 to expand (as shown inFIGS. 17A-17D) upon exiting the delivery device 601 such that thepaddles 606 have a larger surface area for engaging the native valve ofthe patient. The valve repair device 602 can take any suitable form,such as, for example, any form described in the present application. Thevalve repair device 602 can be moved between the open and closedposition, and be attached to a native valve, by a valve repair system,such as, for example, any valve repair system described in the presentapplication.

FIGS. 17A-17C illustrate the valve repair device 602 in the openposition. Referring to FIGS. 17A-17B, when the valve repair device 602is in the expanded and open position, the paddles 606 extend outward tocreate wide opening 614 between the paddles 606 and gripping members 608of the valve repair device 602. In the illustrated embodiment, thehorseshoe shape 1701 of the paddles 606 includes side members 1707 thatextend from a base 1706 of the paddle 606, and a center member 1709 thatextends from the base 1706 and connects to a base assembly 604 of thevalve repair device 602, in which the side members 1707 form a horseshoeshape as shown in FIG. 17C, for example. In certain embodiments, thepaddles 606 include a material 1705 disposed over the horseshoe shape1701 for creating a contact area for the paddles to engage valve tissue.The material 1705 can be any suitable material, such as, for example, awoven material, an electrospun material, or any other material that iscapable of promoting tissue ingrowth and protecting liners of thedelivery device 601 (FIG. 6) during tracking. In certain embodiments,the material 1605 can be a blood-impermeable cloth, such as a PET clothor biocompatible covering material such as a fabric that is treated witha coating that is impermeable to blood, polyester, or a processedbiological material, such as pericardium.

In various embodiments, the paddles 606 are configured to flex to placeless stress on valve tissue when the valve repair device 602 is attachedto the valve tissue. When the paddles 606 are in the expanded condition,the paddles have a width W. The width W can be, for example, betweenabout 4 mm and about 21 mm, such as, between about 5 mm and about 20 mm,such as between about 7.5 mm and about 17.5 mm, such as between about 10mm and about 15 mm. In certain embodiments, the width W can be, forexample, 5 mm or more, such as about 7.5 mm or more, such as about 10 mmor more, such as about 15 mm or more, such as about 20 mm or more. Inother embodiments, the width W can be less than 5 mm. Referring to FIG.17D, in certain embodiments, the thickness T of the paddle is, forexample, between about 0.3 mm and about 0.46 mm, such as between about0.32 mm and about 0.44 mm, such as between about 0.34 mm and about 0.42mm, such as between about 0.36 mm and about 0.40 mm, such as about 0.38mm. In alternative embodiments, the thickness T of the paddle can beless than 0.3 mm or more than 0.46 mm.

Referring to FIG. 17E, the paddles 606 are in a compressed conditionwhen the paddles are disposed in a delivery device 601. When the paddles606 are in the compressed condition, the paddles have a width H. Thewidth H can be, for example between about 4 mm and about 7 mm, such as,between about 5 mm and about 6 mm. In alternative embodiments, the widthH can be less than 4 mm or more than 7 mm. In certain embodiments, thewidth H of the compressed paddles 606 is equal to a width D of thedelivery opening 716 of the delivery device 601. The ratio between thewidth W of the paddles in the expanded condition and the width H of thepaddles in the compressed condition can be, for example, about 4 to 1 orless, such as about 3 to 1 or less, such as about 2 to 1 or less, suchas about 1.5 to 1, such as about 1.25 to 1, such as about 1 to 1. Inalternative embodiments, the ratio between the width W and the width Hcan be more than 4 to 1. Referring to FIG. 17F, a paddle 606 is movedfrom the expanded condition to the compressed condition by compressingthe paddle in the direction Y and extending a length of the paddle inthe direction X. In the illustrated embodiment, the length of the sidemembers 1707 of the paddle 606 are extended when the paddle is in thecompressed condition, but the length of the center member 1709 maintainsthe same length.

Referring to FIGS. 18A-18D, another exemplary embodiment of a valverepair device 602 includes paddles 606 having another horseshoe shape1801. In certain embodiments, the horseshoe shape 1801 of the paddles606 is compressible, which allows the paddles 606 to be disposed in adelivery device 601 (e.g., a catheter) that has a small diameter (asshown in FIG. 18C) for delivery of the valve repair device 602 to anative valve of a patient, and also allows the paddles 606 to expand (asshown in FIGS. 18A-18B) upon exiting the delivery device 601 such thatthe paddles 606 have a larger surface area for engaging the native valveof the patient. The valve repair device 602 can take any suitable form,such as, for example, any form described in the present application. Thevalve repair device 602 can be moved between the open and closedposition, and be attached to a native valve, by a valve repair system,such as, for example, any valve repair system described in the presentapplication.

FIGS. 18A-18B illustrate the valve repair device 602 in the openposition. When the valve repair device 602 is in the open position, thepaddles 606 extend outward to create wide opening 614 between thepaddles 606 and gripping members 608 of the valve repair device 602. Inthe illustrated embodiment, the horseshoe shape 1801 of the paddles 606includes side members 1807 that extend from a base 1806 of the paddle606, and the base 1806 is attached to the base assembly 604 of the valverepair device 602. In certain embodiments, the paddles 606 include amaterial 1805 disposed over the horseshoe shape 1801 for creating acontact area for the paddles to engage valve tissue. The material 1805can be any suitable material, such as, for example, a woven material, anelectrospun material, or any other material that is capable of promotingtissue ingrowth and protecting liners of the delivery device 601 (FIG.6) during tracking. In certain embodiments, the material 1605 can be ablood-impermeable cloth, such as a PET cloth or biocompatible coveringmaterial such as a fabric that is treated with a coating that isimpermeable to blood, polyester, or a processed biological material,such as pericardium.

In various embodiments, the paddles 606 are configured to flex to placeless stress on valve tissue when the valve repair device 602 is attachedto the valve tissue. When the paddles 606 are in the expanded condition,the paddles have a width W. The width W can be, for example, betweenabout 4 mm and about 21 mm, such as, between about 5 mm and about 20 mm,such as between about 7.5 mm and about 17.5 mm, such as between about 10mm and about 15 mm. In certain embodiments, the width W can be, forexample, 5 mm or more, such as about 7.5 mm or more, such as about 10 mmor more, such as about 15 mm or more, such as about 20 mm or more. Inother embodiments, the width W can be less than 5 mm.

Referring to FIG. 18C, the paddles 606 are in a compressed conditionwhen the paddles are disposed in a delivery device 601. When the paddles606 are in the compressed condition, the paddles have a width H. Thewidth H can be, for example between about 4 mm and about 7 mm, such as,between about 5 mm and about 6 mm. In alternative embodiments, the widthH can be less than 4 mm or more than 7 mm. In certain embodiments, thewidth H of the compressed paddles 606 is equal to a width D of thedelivery opening 716 of the delivery device 601. The ratio between thewidth W of the paddles in the expanded condition and the width H of thepaddles in the compressed condition can be, for example, about 4 to 1 orless, such as about 3 to 1 or less, such as about 2 to 1 or less, suchas about 1.5 to 1, such as about 1.25 to 1, such as about 1 to 1. Inalternative embodiments, the ratio between the width W and the width Hcan be more than 4 to 1. Referring to FIG. 18D, a paddle 606 is movedfrom the expanded condition to the compressed condition by compressingthe paddle in the direction Y and extending a length of the paddle inthe direction X. In the illustrated embodiment, the length of the sidemembers 1807 of the paddle 606 are extended when the paddle is in thecompressed condition. Referring to FIG. 18C, in certain embodiments,when the paddles 606 are disposed in the delivery device 601 and in thecompressed condition, the side members 1807 of the paddles cross eachother.

Referring to FIGS. 19A-19D, another exemplary embodiment of a valverepair device 602 includes paddles 606 having a mesh structure 1901. Incertain embodiments, the mesh structure 1901 of the paddles 606 iscompressible, which allows the paddles 606 to be disposed in a deliverydevice 601 (e.g., a catheter) that has a small diameter (as shown inFIG. 19C) for delivery of the valve repair device 602 to a native valveof a patient, and also allows the paddles 606 to expand (as shown inFIGS. 19A-19B) upon exiting the delivery device 601 such that thepaddles 606 have a larger surface area for engaging the native valve ofthe patient. The valve repair device 602 can take any suitable form,such as, for example, any form described in the present application. Thevalve repair device 602 can be moved between the open and closedposition, and be attached to a native valve, by a valve repair system,such as, for example, any valve repair system described in the presentapplication.

FIGS. 19A-19B illustrate the valve repair device 602 in the openposition. When the valve repair device 602 is in the expanded and openposition, the paddles 606 extend outward to create wide opening 614between the paddles 606 and gripping members 608 of the valve repairdevice 602. In certain embodiments, the paddles 606 include a materialdisposed over the mesh structure 1901, such as, for example, a wovenmaterial, an electrospun material, or any other material that is capableof promoting tissue ingrowth and protecting liners of the deliverydevice 601 (FIG. 6) during tracking. In certain embodiments, thematerial 1605 can be a blood-impermeable cloth, such as a PET cloth orbiocompatible covering material such as a fabric that is treated with acoating that is impermeable to blood, polyester, or a processedbiological material, such as pericardium.

In various embodiments, the paddles 606 are configured to flex to placeless stress on valve tissue when the valve repair device 602 is attachedto the valve tissue. When the paddles 606 are in the expanded condition,the paddles have a width W. The width W can be, for example, betweenabout 4 mm and about 21 mm, such as, between about 5 mm and about 20 mm,such as between about 7.5 mm and about 17.5 mm, such as between about 10mm and about 15 mm. In certain embodiments, the width W can be, forexample, 5 mm or more, such as about 7.5 mm or more, such as about 10 mmor more, such as about 15 mm or more, such as about 20 mm or more. Inother embodiments, the width W can be less than 5 mm.

Referring to FIG. 19C, the paddles 606 are in a compressed conditionwhen the paddles are disposed in a delivery device 601. When the paddles606 are in the compressed condition, the paddles have a width H. Thewidth H can be, for example between about 4 mm and about 7 mm, such as,between about 5 mm and about 6 mm. In alternative embodiments, the widthH can be less than 4 mm or more than 7 mm. In certain embodiments, thewidth H of the compressed paddles 606 is equal to a width D of thedelivery opening 716 of the delivery device 601. The ratio between thewidth W of the paddles in the expanded condition and the width H of thepaddles in the compressed condition can be, for example, about 4 to 1 orless, such as about 3 to 1 or less, such as about 2 to 1 or less, suchas about 1.5 to 1, such as about 1.25 to 1, such as about 1 to 1. Inalternative embodiments, the ratio between the width W and the width Hcan be more than 4 to 1. Referring to FIG. 19D, a paddle 606 is movedfrom the expanded condition to the compressed condition by compressingthe paddle in the direction Y and extending a length of the paddle inthe direction X.

Referring to FIGS. 20A-20B, another exemplary embodiment of a valverepair device includes paddles 606 that are compressible, which allowsthe paddles 606 to be disposed in a delivery device 601 (e.g., acatheter) that has a small diameter (as shown in FIG. 20A) for deliveryof the valve repair device to a native valve of a patient, and alsoallows the paddles 606 to expand (as shown in FIG. 20B) upon exiting thedelivery device 601 such that the paddles 606 have a larger surface areafor engaging the native valve of the patient. The paddles 606 can beincluded on a valve repair device 602 that takes any suitable form, suchas, for example, any form described in the present application. Thevalve repair device (and paddles 606) can be attached to a native valveby a valve repair system, such as, for example, any valve repair systemdescribed in the present application.

FIG. 20A illustrates the paddle 606 in a compressed condition inside adelivery device 601. The paddle includes an opening 2001 that allows aportion of the paddle to expand upon being deployed from the deliverydevice 601. In the compressed condition, the paddle 606, for example,can have a width H between about 4 mm and about 7 mm, such as, betweenabout 5 mm and about 6 mm. In alternative embodiments, the width H canbe less than 4 mm or more than 7 mm. In certain embodiments, the width Hof the compressed paddles 606 is equal to a width D of the deliveryopening 716 of the delivery device 601. FIG. 20B illustrates the paddle606 in an expanded condition. In the expanded condition, the paddle 606,for example, can have a width W between about 4 mm and about 21 mm, suchas, between about 5 mm and about 20 mm, such as between about 7.5 mm andabout 17.5 mm, such as between about 10 mm and about 15 mm. In certainembodiments, the width W can be, for example, 5 mm or more, such asabout 7.5 mm or more, such as about 10 mm or more, such as about 15 mmor more, such as about 20 mm or more. In other embodiments, the width Wcan be less than 5 mm. The ratio between the width W of the paddles inthe expanded condition and the width H of the paddles in the compressedcondition can be, for example, about 4 to 1 or less, such as about 3 to1 or less, such as about 2 to 1 or less, such as about 1.5 to 1, such asabout 1.25 to 1, such as about 1 to 1. In alternative embodiments, theratio between the width W and the width H can be more than 4 to 1.Referring to FIG. 20B, a paddle 606 is moved from the expanded conditionto the compressed condition by compressing the paddle in the directionY. In various embodiments, the paddles 606 are configured to flex toplace less stress on valve tissue when the valve repair device 602 isattached to the valve tissue. In certain embodiments, the paddles 606include a material disposed over the paddle 606, such as, for example,any material that is capable of promoting tissue ingrowth and protectingliners of the delivery device 601 (FIG. 6) during tracking. In certainembodiments, the material can be a blood-impermeable cloth, such as aPET cloth or biocompatible covering material such as a fabric that istreated with a coating that is impermeable to blood, polyester, or aprocessed biological material, such as pericardium.

FIGS. 21A-21B illustrate another exemplary embodiment of a valve repairsystem 600, in which the valve repair system 600 includes a valve repairdevice 602 having extendable paddles. The valve repair system 600 cantake any suitable form, such as, for example, any form described in thepresent application. In the illustrated embodiment, the valve repairdevice 602 includes paddles 606 that are telescoping such that a lengthL of the paddles can be altered. That is, the paddles 606 include a mainportion 2110 and an extendable portion 2112. The extendable portion 2112is able to be housed within the main portion 2110 to create paddleshaving a shorter length L (as shown in FIG. 21A), and the extendableportion 2112 is able to be extended outside of the main portion tocreate paddles having a longer length L (as shown in FIG. 21B). Theratio between the shorter length L (as shown in FIG. 21A) and the longerlength L (as shown in FIG. 21B) can be, for example, 1.25 to 1 or more,such as 1.5 to 1 or more, such as 2 to 1 or more, such as 2 to 1 ormore, such as 4 to 1 or more, such as 5 to 1 or more.

In one embodiment, the main portion 2110 is a hollow conduit having anopening, and the extendable portion 2112 is a rod or conduit configuredto be housed in the opening of the hollow member. In certainembodiments, the extendable portion 2112 is spring loaded, such that theextendable portion 2112 is biased toward the extended position, and alatch member is disposed in a locked position to maintain the extendableportion 2112 housed within the main portion 2110 in the non-extendedposition. Movement of the latch member from the locked position to anunlocked position causes the spring-loaded extendable portion 2112 tomove outside the main portion 2110 and into the extended position. Inaddition, the extendable portion 2112 can be moved back within the mainportion 2110 and the latch member can be moved from the unlockedposition to the locked position to move the paddles from the extendedposition to the retracted position. The latch member can be movedbetween the locked an unlocked position by any suitable means, such as,for example, a rod that engages the latch member to move the latchmember between the locked and unlocked positions. In an alternativeembodiment, a suture or wire extends through the main portion 2110 andengages the extendable portion 2112 to maintain the extendable portion2112 in the non-extended position, and removal of the suture or wireallows the spring-loaded extendable portion to move outside the mainportion 2110 and into the extended position.

Referring to FIG. 21A, the valve repair device 602 is shown with thepaddles 606 in a non-extended position, and the valve repair device ispositioned to engage valve tissue 820. Referring to FIG. 21B, after thevalve repair device 602 is placed in position to engage the valve tissue820, the extendable portions 2112 of the paddles 606 are extended suchthat the paddles have a larger surface area for engaging the valvetissue. After the paddles 606 are extended to a desired length L, thevalve repair device 602 is closed to secure the valve repair device tothe valve tissue 820, and the valve repair device is removed from thevalve repair system 600. In certain embodiments, the valve repair device602 is configured such that the extendable portions 2112 of the paddlescan be extended or retracted after the valve repair device is secured tothe valve tissue 820, such that the tension on the valve tissue can beincreased or decreased depending on the patient and the proceduralcircumstances. For example, in embodiments in which the valve tissue 820is a patient's mitral valve, a valve with excess leaflet material orchordal damage may need more tension to sufficiently seal the mitralvalve, or a valve with short non-coapting leaflets may need less tensionfor a sufficiently seal the mitral valve. The valve repair device can bemoved from the open position to a closed position and removed from thevalve repair system 600 in any suitable manner, such as, for example,any manner described in the present application.

Referring to FIGS. 22-26, in certain embodiments, the gripper controlmechanism 611 is configured to control each of the gripping members 608independent of each other. Independent control for each of the grippingmembers 608 is advantageous because the openings 614 between the paddles606 and the gripping members can be adjusted independently as the valverepair device 602 is being attached to valve tissue (e.g., a mitralvalve of a patient). In addition, independent gripper control will alsobe advantageous in situations in which one gripping member 608 and onepaddle 606 sufficiently secure the valve repair device 602 to a firstportion of valve tissue, but the other gripping member and the otherpaddle fail to connect the valve repair device to a second portion ofvalve tissue. In this situation, the gripper control mechanism 611 canbe used to control only the gripping member 608 that is not connected tothe valve tissue to create an opening 614 for receiving the secondportion of the valve tissue, and, after the second portion of the valvetissue is disposed in the opening, the unattached gripping member andthe unattached paddle can be closed to secure the valve repair device602 to the second portion of the valve tissue.

Still referring to FIGS. 22-26, an exemplary embodiment of a valverepair system 600 includes a delivery device 601 and a valve repairdevice 602, in which delivery device is configured to deliver the valverepair device to the native valve of a patient, and in which the valverepair device is configured to attach to leaflets of a native valve torepair the native valve of the patient. The delivery device 601 can takeany suitable form that is capable of delivering the valve repair device602 to the native valve of a patient, such as, for example, any formdescribed in the present application. The valve repair device 602 issimilar to the previously described valve repair device and includes abase assembly 604, a pair of paddles 606, and a pair of gripping members608. The base assembly 604 of the valve repair device 602 has a shaft603, a coupler 605 configured to move along the shaft, and a lock 607configured to lock the coupler in a stationary position on the shaft.The valve repair device 602 can take any suitable form, such as, forexample, any form described in the present application. The valve repairsystem 600 can also include a paddle control mechanism 610, a grippercontrol mechanism 611, and a lock control mechanism 612. The paddlecontrol mechanism 610 is mechanically attached to the coupler 605 tomove the coupler along the shaft 603, which causes the paddles 606 tomove between the open and closed positions. The paddle control mechanism610 can take any suitable form, such as, for example, any form describedin the present application. The lock control mechanism 612 is configuredto move the coupler 605 between the locked and unlocked conditions. Thelock control mechanism 612 can take any suitable form, such as, forexample, any form described in the present application.

Referring to FIG. 22, an exemplary embodiment of a gripper controlmechanism 611 includes a first gripper control member 2202 and a secondgripper control member 2204. The first gripper control member 2202 isconfigured to move the gripping member 608 a in the direction X, and thesecond gripper control member 2204 is configured to move the grippingmember 608 b in the direction Z. Movement of the gripping member 608 ain the direction X will adjust the width W of the opening 614 a betweenthe gripping member 608 a and the paddle 606 a, and movement of thegripping member 608 b in the direction Z will adjust the width H of theopening between the gripping member 608 b and the paddle 606 b. Thegripper control members 2202, 2204 can take any suitable form that iscapable of independently moving the gripping members 608 a, 608 b. Inthe illustrated embodiment, the gripper control members 2202, 2204 arelines, such as sutures, wires, etc. that are removably attached to eachof the gripper members 608 a, 608 b, respectively, with both ends of theline extending through the delivery opening 716 of the delivery device601. The gripper control members 2202, 2204 can be independently pulledinto and cast from the catheter to independently control the positionsof the gripping members 608 a, 608 b.

Referring to FIGS. 22A-22D, another exemplary embodiment of valve repairsystem 600 is shown with another embodiment of a gripper controlmechanism 611 used to control the gripping members 608 a-d of anotherexemplary embodiment of a valve repair device 602. For illustrativepurposes, the paddles 606 of the valve repair device 602 are not shownon in FIGS. 22A-22D, but it should be noted that the valve repair device602 also includes paddles 606 that interact with the gripping members608 a-d to secure the valve repair device 602 to valve tissue, and thepaddles 606 can take any suitable form, such as, for example, any formdescribed in the present application. FIG. 22A illustrates the valverepair system 600 with the each of the four gripping members 608 a-d ina first position, and FIG. 22C illustrates the valve repair system 600with the one of the gripping members 608 a moved to a second position.FIG. 22B is a top view (as indicated by the lines 22B-22B shown in FIG.22A) of the valve repair system 600 with each of the gripping members608 a-d being disposed in a first position. FIG. 22D is across-sectional view (as indicated by the lines C-C shown in FIG. 22C)of the valve repair system 600 with the gripping member 608 a disposedthe second position. Each of the four gripping members can beindependently moved in the same manner as is illustrated by the grippingmember 608 a.

The valve repair device 602 includes a first gripping member 608 a, asecond gripping member 608 b, a third gripping member 608 c, and afourth gripping member 608 d. Each of the gripping members 608 a-dinclude a barbed portion 609 a-d for securing the gripping members 608a-d to valve tissue. The gripper control mechanism 611 includes a firstgripper control member 2202 a configured to control the first grippingmember 608 a, a second gripper control member 2202 b configured tocontrol the second gripping member 608 b, a third gripper control member2202 c configured to control the third gripping member 608 c, and afourth gripper control member 2202 d configured to control the fourthgripping member 608 d. In particular, the first gripper control member2202 a is configured to move the gripping member 608 a in the directionX, and the second gripper control member 2202 b is configured to movethe second gripping member 608 b in the direction X. In addition, thethird gripper control member 2202 c is configured to move the grippingmember 608 c in the direction Z, and the fourth gripper control member2202 d is configured to move the fourth gripping member 608 d in thedirection Z. Movement of the gripping members 608 a-b in the direction Xwill adjust the width of the opening between the gripping members 608a-b and the corresponding paddle 606, and movement of the grippingmembers 608 c-d in the direction Z will adjust the width of the openingbetween the gripping members 608 c-d and the corresponding paddle. Thegripper control mechanism 611 is configured to move each of the grippingmembers 608 a-d independently of each other. The gripper control members2202 a-d can take any suitable form that is capable of independentlymoving the gripping members 608 a-d. In the illustrated embodiment, thegripper control members 2202 a-d are lines, such as sutures, wires, etc.that are removably attached to each of the gripper members 608 a-d,respectively, with both ends of the line extending through the deliveryopening 716 of the delivery device 601. The gripper control members 2202a-d can be independently pulled into and released from the catheter toindependently control the positions of the gripping members 608 a-d.

Referring to FIGS. 22A and 22B, each of the gripping members 608 a-d areshown in an extended position. Referring to FIGS. 22C and 22D, the firstgripping member 608 a is shown after the first gripper control member2202 a of the gripper control mechanism was pulled into the cathetercauses the first gripping member 608 a to move inward toward the shaft603 in the direction X, and the other gripping members 608 b-d remainedin the position shown in FIGS. 22A and 22B. In other words, theillustrated embodiment shown in FIGS. 22A-22D show a first grippingmember 608 a being independently controlled relative to the othergripping members 608 b-d. While the illustrated embodiment shows thefirst gripping member 608 a being independently controlled, it should beunderstood that each of the gripping members 608 a-d can beindependently controlled by the corresponding gripper control member2202 a-d of the gripper control mechanism 611. In addition, while theillustrated embodiment of FIGS. 22A-22D illustrate a valve repairassembly 600 having four gripping members 608 a-d and four grippercontrol members 2202 a-d, it should be understood that any suitablenumber of gripping members and gripper control members can be utilized,and any number of the gripping members can be independently controlledby the gripper control mechanism. In addition, each of the grippingmembers 608 a-608 d can have any of the configurations disclosed in thisapplication and each of the control mechanisms 2202 a-2202 d can haveany of the forms disclosed in this application.

Referring to FIG. 23, another exemplary embodiment of a gripper controlmechanism 611 includes a single line 2302, such as a suture or wire,that is removably attached to the gripping members 608 a, 608 b andremovably fixed between a placement shaft 613 and a 603 shaft of thevalve repair device. The connection 615 between the placement shaft 613and a 603 shaft of the valve repair device can be at a wide variety ofdifferent positions. In the illustrate example, the connection 615 isaligned or substantially aligned with ends of the gripping members 608a, 608 b. However, in other embodiments, the connection 615 can moredistal, such as at a most proximal position that the coupler 605 canreach (see for example, the bailout positions of the coupler illustratedby FIGS. 45C and 46D). The single line 2302 is connected between theshaft 613 and the shaft 603, such that the single line 2302 canindependently control the gripping members 608 a, 608 b. That is,movement of a first portion 2303 of the line 2302 in the direction Ywill adjust the width W between the gripping member 608 a and the paddle606 a, but will not adjust the width H between the gripping member 608 band the paddle 606 b. Similarly, movement of a second portion 2305 ofthe line 2302 in the direction M will adjust the width H between thegripping member 608 b and the paddle 606 b, but will not adjust thewidth W between the gripping member 608 a and the paddle 606 a. Afterthe valve repair device 602 is in the closed position and secured tovalve tissue, the placement shaft 613 is detached from the shaft 603 ofthe valve repair device 602. The detachment of the shaft 603 from theand the shaft 613 causes the line to be released. The line 2302 can thenbe retracted into the catheter to release the gripping members 608 a,608 b by pulling one end of the line 2302 into the catheter. Pulling oneend of the line into the catheter pulls the other end of the linethrough the gripping members 608 a, 608 b and then into the catheter.Any of the lines described herein can be retracted in this manner.

Referring to FIG. 24, in certain embodiments, the placement shaft 613and the shaft 603 of the device 602 can be a hollow an fit over acoupling shaft 2400 that holds the shafts 613, 603 together. The shaft603 of the device 602 can include a protruding portion 2406 and arecessed receiving portion 2408. The positioning shaft 613 can include aprotruding portion 2407 and a recessed receiving portion 2409. When theshafts 613, 603 are coupled, the protruding portion 2406 of the shaft603 is disposed in the receiving portion 2409 of the shaft 613, and theprotruding portion 2407 of the shaft 613 is disposed in the receivingportion 2408 of the shaft 603. The shafts 613, 603 can be connected in awide variety of different ways. For example, the shaft 613 can include abore or channel 2411 that is aligned with a bore or channel 2413 of theshaft 602 when the protruding portions 2406, 2407 are disposed in thereceiving portions 2408, 2409, respectively. When the openings 2411,2413 are aligned and the retaining shaft 2400 is placed into theopenings 2411, 2413 in the direction X, the shafts 613, 603 are retainedtogether. When the placement shaft is removed from the openings 2411,2413 in the direction Z, protruding portions 2406, 2407 can be removedfrom the receiving portions 2408, 2409, such that the device 602 isdetached from the placement shaft 613.

Still referring to FIG. 24, when the shafts 613, 603 are secured to eachother, an aperture 2415 is created at interface 2417 between the shafts613, 603. The aperture 2415 is configured to secure the line 2302between the shafts 613, 603 to allow for independent control of thegripping members 608 a, 608 b. That is, the aperture 2415 is configuredsuch that the line 2302 does not move relative to the aperture 2416 whenthe shafts 613, 603 are attached. Upon detachment of the shafts 613,603, the line 2302 is released from the aperture 2415 and can be removedfrom the valve repair device 602. The line 2302 can then be retractedinto the catheter to release the gripping members as described above.

Referring to FIGS. 23 and 24A-24B, in an alternative embodiment, theline 2302 of the gripper control mechanism 610 is secured between theplacement shaft 613 and the shaft 603 of by a threaded connection toindependently control the gripper members 608 a, 608 b. Referring toFIG. 24A, the placement shaft 613 includes a male threaded member 2419,and the shaft 603 includes a female threaded member 2421 configured toreceive the male threaded member 2419 of the placement shaft 613.However, the male and female threads can be reversed. The placementshaft 613 is secured to the shaft 603 by inserting the male threadedmember 2419 into the female threaded member 2421 of the shaft 603. Theline 2302 of the gripper control mechanism 611 is disposed between theplacement shaft 613 and the shaft 603 such that, when the placementshaft 613 is secured to the shaft 603, the line 2302 is compressed (asshown by reference character M) between the placement shaft 613 and theshaft 603. The compression M of the line 2302 between the placementshaft 613 and the shaft 603 causes the line 2302 to not move relative tothe engagement point 2423 between the placement shaft 613, the shaft603, and the line 2302 when the line 2302 is controlling the grippingmembers 608 a, 608 b. As a result, the compression M and resultingretention of the line 2302 allows the line 2302 to independently controlthe gripping members 608 a, 608 b.

Referring to FIG. 25, another exemplary embodiment of a gripper controlmechanism 611 includes a first gripper control member 2502 and a secondgripper control member 2504. The first gripper control member 2502 isconfigured to move the gripping member 608 a bi-directionally in thedirection X, and the second gripper control member 2504 is configured tomove the gripping member 608 b bi-directionally in the direction Z.Movement of the gripping member 608 a in the direction X will adjust thewidth W of the opening 614 a between the gripping member 608 a and thepaddle 606 a, and movement of the gripping member 608 b in the directionZ will adjust the width H of the opening between the gripping member 608b and the paddle 606 b. In the illustrated embodiment, the grippercontrol members 2202, 2204 include a push/pull link 2503, 2505, such as,for example, a catheter, a flexible rod, or a stiff wire and a coupler2506, 2507. Each push/pull link 2503, 2505 extends from the deliverydevice 601 and is removably attached to the corresponding grippingmember 608 a, 608 b by a coupler 2506, 2507. The link 2503 is configuredto be pushed and pulled in the direction Y. Movement of the link 2503 inthe direction Y causes the gripping member 608 a to move in thedirection X. Similarly, the link 2505 is configured to be pushed andpulled in the direction M, and movement of the catheter 2505 in thedirection M causes the catheter 2505 to move the gripping member 608 bin the direction H.

In another embodiment of a the gripper control mechanism 611 is shown inFIG. 25A. in this embodiment, the gripper control members 2202, 2204include a suture 2511, 2513 and a flexible wire 2503, 2505. In thisembodiment, the first flexible wire 2503 includes a loop 2517 forreceiving the first suture 2511 and for engaging a gripping member 608 a(FIG. 25), and the second flexible wire 2505 includes a loop 2519 forreceiving the second suture 2513 and for engaging the gripping member608 b (FIG. 25). The sutures 2517, 2519 are removably attached to eachof the gripper members 608 a, 608 b, respectively, with both ends of theline extending through the delivery device 601 as described above. Eachof the wires 2503, 2505 extends from the delivery device 601 and theloops 2517, 2519 of the respective wires 2503, 2505 are able to movealong the corresponding sutures 2511, 2513, such that the loops 2517,2519 can engage the corresponding gripping member 608 a, 608 b to movethe gripping members (e.g., move the gripping members as described withrespect to FIG. 25). The wires 2503, 2505 can be made of, for example,steel, NiTi, or other wire or a plastic material. In certainembodiments, the wires 2503, 2505 can have a diameter of between about0.1 mm and 0.35 mm, such as between about 0.15 mm and 0.3 mm, such asbetween about 0.2 mm and 0.25 mm.

Referring to FIG. 26, another exemplary embodiment of a gripper controlmechanism 611 includes a first catheter 2603, a second catheter 2605,and single line 2604, such as a wire or suture. The first catheter 2603and line 2604 are configured to move the gripping member 608 a in thedirection X, and the second catheter 2605 and line 2604 configured tomove the gripping member 608 b in the direction Z. Movement of thegripping member 608 a in the direction X will adjust the width W of theopening 614 a between the gripping member 608 a and the paddle 606 a,and movement of the gripping member 608 b in the direction Z will adjustthe width H of the opening between the gripping member 608 b and thepaddle 606 b. The line 2604 extends from the delivery device 601 throughthe catheters 2603, 2605 and is threaded through openings in bothgripping member 608 a, 608 b. Each catheter 2603, 2605 is configured toengage and move the corresponding gripping member 608 a, 608 b. Inparticular, the catheter 2603 is configured to be pushed in thedirection Y while the line 2604 is payed out of the catheter 2603 ortension in the line is reduced. The catheter 2603 is configured to bepulled in the direction Y while the line 2604 is pulled into thecatheter 2603 or tension in the line is increased. Movement of thecatheter 2603 in the direction Y causes the catheter 2603 to move thegripping member 608 a in the direction X. Similarly, the catheter 2605is configured to be pushed in the direction M while the line 2604 ispayed out of the catheter 2605 or tension in the line is reduced. Thecatheter 2605 is configured to be pulled in the direction M while theline 2604 is pulled into the catheter 2605 or tension in the line isincreased. Movement of the catheter 2505 in the direction M causes thecatheter 2505 to move the gripping member 608 b in the direction H. Inan alternative embodiment, the gripper control mechanism 611 describedabove with reference to FIG. 26 can include a first flexible wire with aloop (e.g., the flexible wire 2503 with the loop 2517 shown in FIG. 25A)and a second flexible wire with a loop (e.g., the flexible wire 2505with the hoop 2519 shown in FIG. 25A), and the single line 2604 extendsthrough the hoop 2517, 2519 of each of the wires 2503.

Referring to FIGS. 27A-29B, in certain embodiments, the valve repairdevice 602 and the paddle control mechanism 610 for a valve repairdevice 602 are configured such that each of the paddles 606 can becontrolled independent of each other. Independent control for each ofthe paddles 606 is advantageous because the openings 614 between thepaddles and the gripping members 608 can be adjusted independently asthe valve repair device 602 is being attached to valve tissue (e.g., amitral valve of a patient). In addition, independent paddle control willalso be advantageous in situations in which one gripping member 608 andone paddle 606 sufficiently secure the valve repair device 602 to afirst portion of valve tissue, but the other gripping member and theother paddle fail to connect the valve repair device to a second portionof valve tissue. In this situation, the paddle control mechanism 610 canbe used to control only the paddle 606 that is not connected to thevalve tissue to create an opening 614 for receiving the second portionof the valve tissue, and, after the second portion of the valve tissueis disposed in the opening, the unattached gripping member and theunattached paddle can be closed to secure the valve repair device 602 tothe second portion of the valve tissue.

Referring to FIGS. 27A-27C, the base assembly 604 of the valve repairdevice 602 includes a first shaft 603 a, a second shaft 603 b, a firstcoupler 605 a, and a second coupler 605 b. In addition, the paddlecontrol mechanism 610 includes a first paddle control mechanism 2702 anda second paddle control mechanism 2704. The first paddle controlmechanism 2702 is configured to move the first coupler 605 a along theshaft 603 a, and the second paddle control mechanism 2704 is configuredto move the second coupler 605 b along the shaft 603 b. Movement of thefirst coupler 605 a along the shaft 603 a causes the paddle 606 a tomove between an open position and a closed position, and movement of thesecond coupler 605 b along the shaft 603 b causes the paddle 606 b tomove between an open position and a closed position. In an alternativeembodiment, the base assembly 604 can include a single shaft, a firstcoupler 605 a attached to the single shaft, and a second coupler 605 battached to the single shaft. In this alternative embodiment, the paddlecontrol mechanism 610 can include a first paddle control mechanism 2702configured to move the first coupler 605 a along the single shaft tocause the paddle 606 a to move between an open position and a closedposition, and a second paddle control mechanism 2704 configured to movethe second coupler 605 b along the single shaft to cause the paddle 606b to move between an open position and a closed position.

FIGS. 27A-27C illustrate the paddles of the valve repair device movingbetween an open position and a closed position. The base assembly 604 ofthe valve repair device 602 includes a first link 2721 extending frompoint A to point B, a second link 2722 extending from point B to pointC, a third link 2723 extending from point C to point D, a fourth link2724 extending from point D to point E, and a fifth link 2725 extendingfrom point E to point F. The coupler 605 a is movably attached to theshaft 603 a, the coupler 605 b is movably attached to the shaft 603 b,and the shafts 603 a, 603 b are fixed to the third link 2723. The firstlink 2721 is pivotally attached to the coupler 605 a at point A, suchthat movement of the coupler 605 a along the shaft 603 a moves thelocation of point A and, consequently, moves the first link 2721.Similarly, the fifth link 2725 is pivotally attached to the coupler 605b at point F, such that movement of the coupler 605 b along the shaft603 b moves the location of point F and, consequently moves the fifthlink 2725. The first link 2721 and the second link 2722 are pivotallyattached to each other at point B, and the fifth link 2725 and thefourth link 2724 are pivotally attached to each other at point E. Onepaddle 606 a is attached to the first link 2721 such that movement ofthe first link 2721 causes the paddle 606 a to move, and the otherpaddle 606 b is attached to the fifth link 2725 such that movement ofthe fifth link 2725 causes the paddle 606 b to move.

Referring to FIG. 27A, the paddles 606 a, 606 b are in the openposition. Referring to FIGS. 27A and 27B, the paddle 606 b is moved fromthe open position (as shown in FIG. 27A) to the closed position (asshown in FIG. 27B) when the second paddle control mechanism 2704 movesthe second coupler 605 b along the shaft 603 b in the direction Y, whichcauses a portion of the fifth link 2725 near point F to move in thedirection H, and a portion of the fifth link 2725 near point E to movein the direction J. The paddle 606 b is attached to the fifth link 2725such that movement of the second coupler 605 b in the direction Y causesthe paddle 606 b to move in the direction Z. In addition, the fourthlink 2724 is pivotally attached to the fifth link 2725 at point E suchthat movement of the second coupler 605 b in the direction Y causes thefourth link 2724 to move in the direction K. Referring to FIG. 27B, thepaddle 606 b moves in the direction Q when moving from the open positionto the closed position. In an alternative embodiment in which thepivotal connection at point E between the fourth link 2724 and the fifthlink 2725 is significantly lower than pivotal connection at point Fbetween the fifth link 2725 and the second coupler 605 b, movement ofthe paddle 606 b from the open position to the closed position will actas shown in the embodiment shown in FIG. 27A except that the fourth link2724 will initially move in the direction substantially opposite to thedirection K as the paddle 606 b is being closed. In any of theabove-mentioned embodiments, the second paddle control mechanism 2704can take any suitable form for moving the second coupler 605 b along theshaft 603 b, such as, for example, any form of a paddle controlmechanism described in the present application.

Referring to FIGS. 27A and 27C, the paddle 606 a is moved from the openposition (as shown in FIG. 27A) to the closed position (as shown in FIG.27C) when the first paddle control mechanism 2702 moves the firstcoupler 605 a along the shaft 603 a in the direction N, which causes aportion of the first link 2721 near point A to move in the direction L,and a portion of the first link 2721 near point B to move in thedirection I. The paddle 606 a is attached to the first link 2721 suchthat movement of the first coupler 605 a in the direction N causes thepaddle 606 a to move in the direction V. In addition, the second link2722 is pivotally attached to the first link 2721 at point B such thatmovement of the first coupler 605 a in the direction N causes the secondlink 2722 to move in the direction R. Referring to FIG. 27C, the paddle606 a moves in the direction T when moving from the open position to theclosed position. In an alternative embodiment in which the pivotalconnection at point B between the first link 2721 and the second link2722 is significantly lower than pivotal connection at point A betweenthe first link 2721 and the first coupler 605 a, movement of the paddle606 a from the open position to the closed position will act as shown inthe embodiment shown in FIG. 27A except that the second link 2722 willinitially move in the direction substantially opposite to the directionR as the paddle 606 b is being closed. In any of the above-mentionedembodiments, the first paddle control mechanism 2702 can take anysuitable form for moving the first coupler 605 a along the shaft 603 a,such as, for example, any form of a paddle control mechanism describedin the present application.

Referring to FIGS. 28A-28C, in certain embodiments, the paddle controlmechanism 610 includes a rack and pinion mechanism 2802 that isconfigured to selectively couple and decouple the paddles 606 a, 606 bfrom the shaft 603. The rack and pinion mechanism 2802 includes a firstmember 2804 attached to the shaft 603 and a toothed member 2806 a, 2806b attached to each of the paddles 606 a, 606 b and pivotally connectedto a base member 2801 at connections points A, B. The first member 2804is configured such that the paddles 606 a, 606 b can be moved betweenthe open and closed positions independent of each other. In theillustrated embodiment, the first member 2804 has ribbed portion 2805and an open portion 2807. When the toothed member(s) 2806 a, 2806 b isaligned with the ribbed portion 2805 of the first member 2804, thetoothed member(s) 2806 a, 2806 b are configured to engage the ribbedportion 2805 such that movement of the shaft in the direction Y relativeto the base member 2801 causes the toothed member 2806 a to pivot aboutconnection point A in the direction M to move the paddle 606 a betweenan open position and a closed position in the direction H, and causesthe toothed member 2806 b to pivot about connection point B in thedirection N to move the paddle 606 b between an open position and aclosed position in the direction Z. When the open portion 2807 of thefirst member 2804 is aligned with either of the toothed members 2806 aor 2806 b, the tooth member that is aligned with the open portion 2807is not engaged by the ribbed portion 2805 of the paddle 606 a or 606 b.As a result, movement of the shaft 603 in the direction Y does notaffect the position of the paddle 606 a or 606 b.

FIGS. 28A-28B illustrate the corkscrew mechanism 2802 in a firstposition. In the first position, the toothed members 2806 a, 2806 b forboth paddles 606 a, 606 b are aligned with the ribbed portion 2805 ofthe first member 2804. Referring to FIG. 28A, when the shaft 603 ismoved in the direction Y, the toothed members 2806 a, 2806 b both engagethe ribbed portion 2805 of the first member, which causes both paddles606 a, 606 b to be moved between the open and closed positions. FIGS.28C-28D illustrate the corkscrew mechanism 2802 in a second position. Inthe second position, the toothed member 2806 a is aligned with the openportion 2807 of the first member 2804, and the toothed member 2806 b isaligned with the ribbed portion 2806 of the first member 2804. Referringto FIG. 28C, when the shaft 603 is moved in the direction Y, the toothedmember 2806 b engages the ribbed portion 2805 of the first member 2804,which causes the paddle 606 b to be moved between the open and closedpositions, and the toothed member 2806 a does not engage the firstmember, which causes the paddle 606 a to remain in a current position.FIGS. 28E-28F illustrate the corkscrew mechanism 2802 in a thirdposition. In the third position, the toothed member 2806 b is alignedwith the open portion 2807 of the first member 2804, and the toothedmember 2806 a is aligned with the ribbed portion 2806 of the firstmember 2804. Referring to FIG. 28E, when the shaft 603 is moved in thedirection Y, the toothed member 2806 a engages the ribbed portion 2805of the first member 2804, which causes the paddle 606 a to be movedbetween the open and closed positions, and the toothed member 2806 bdoes not engage the first member, which causes the paddle 606 b toremain in a current position. In certain embodiments, the rack andpinion mechanism 2802 is moved between the positions shown in FIGS.28A-28F by rotating the shaft 603. In various embodiments, the rack andpinion mechanism 2802 includes a mechanism configured to maintain thepaddles 606 a, 606 b in a desired position when the paddles are alignedwith the open portion 2807 of the first member 2804, but is alsoconfigured to allow the paddles to move when the paddles are alignedwith the ribbed portion 2805 of the first member 2804. The mechanism cantake any suitable form, such as, for example, a clutch mechanism, abiasing member, a friction element, etc.

Referring to FIGS. 29A-29B, the paddle control mechanism 610 isconfigured to move a coupler 605 along a shaft 603 to move the paddles606 a, 606 b between the open and closed positions (similar to theembodiment shown in FIGS. 6-12), and a locking mechanism 207 isconfigured to lock the coupler 605 on the shaft 603 to maintain thepaddles 606 a, 606 b in a desired position. In certain embodiments, asshown in FIGS. 29A-29B, each of the paddles 606 a, 606 b include a pin2902 a, 2902 b and a slot 2904 a, 2904 b. The pin 2902 a is configuredto move in slot 2904 a, and the pin 2902 b is configured to move in slot2904 b. The pins 2902 a, 2902 b are also configured to be locked in theslots 2904 a, 2904 b. When a pin 2902 a, 2902 b is unlocked in a slot2904 a, 2904 b, the corresponding paddle 606 a, 606 b remains in acurrent position when the paddle control mechanism 610 moves the coupler605 along the shaft 603. When a pin 2902 a, 2902 b is locked in a slot2904 a, 2904 b, the corresponding paddle 606 a, 606 b moves between anopen and closed position when the paddle control mechanism 610 moves thecoupler 605 along the shaft 603.

FIG. 29A illustrates the valve repair device 602 with the paddles 606 a,606 b in an open position. FIG. 29B illustrates the valve repair device602 with the pin 2902 a unlocked in slot 2904 a, and pin 2902 b lockedin slot 2904 b. Referring to FIG. 29B, the lock 607 is in an unlockedcondition such that the coupler 605 can be moved along the shaft 603.Movement of the coupler 605 along the shaft 603 in the direction Ycauses the paddle 606 b to pivot about the locked pin 2902 b such thatthe paddle 606 b moves in the direction Z to a closed position. Inaddition, movement of the coupler 605 in the direction Y does not causethe paddle 606 a to move because the pin 2902 a is in an unlockedcondition in the slot 2904 a. Instead, movement of the coupler 605 inthe direction Y causes the pin 2902 a to move in the slot 2904 a.Alternatively, the pin 2902 a could be locked in slot 2904 a and the pin2902 b could be unlocked in slot 2904 b, such that movement of thecoupler 605 in the direction Y would cause the paddle 606 a to move to aclosed position, and the paddle 606 b to remain in the open position (bythe pin 2902 b moving in the slot 2904 b). In addition, the pin 2902 acould be locked in slot 2904 a and the pin 2902 b could be locked inslot 2904 b, such that movement of the coupler 605 in the direction Ywould cause both paddles 606 a, 606 b to move to the closed position.The pins 2902 a, 2902 b can be locked in the slot 2904 a, 2904 b by anysuitable means, such as, for example, any means described herein withreference to lock 607.

Referring to FIG. 30, in certain situations, the mitral valve 3001 of apatient can have a wide gap 3002 between the anterior leaflet 3003 andthe posterior leaflet 3004 when the mitral valve is in a closed position(i.e., during the systolic phase). For example, the gap 3002 can have awidth W between about 2.5 mm and about 17.5 mm, such as between about 5mm and about 15 mm, such as between about 7.5 mm and about 12.5 mm, suchas about 10 mm. In some situations, the gap 3002 can have a width Wgreater than 15 mm. In any of the above-mentioned situations, a valverepair device is desired that is capable of engaging the anteriorleaflet 3003 and the posterior leaflet 3004 to close the gap 3002 andprevent regurgitation of blood through the mitral valve 3001.

FIGS. 31A-37D provide various embodiments of valve repair devices 602that are configured to close a wide gap 3002 (FIG. 30) between theanterior leaflet 3003 and posterior leaflet 3004 of a mitral valve 3001.Referring to FIGS. 31A-31B, an exemplary embodiment of a valve repairdevice 602 includes paddles 606 and gripping members 608. In addition,the valve repair device 602 can include any other features for a valverepair device discussed in the present application, and the valve repairdevice 602 can be positioned to engage valve tissue 820 as part of anysuitable valve repair system (e.g., any valve repair system disclosed inthe present application). Referring to FIG. 31A, the paddles 606 of thevalve repair device 602 are pivoted outward in the direction X to createan opening 614 between the paddles 606 and the gripping members 608having a width W. The width W can be, for example, between about 5 mmand about 15 mm, such as between 7.5 mm and about 12.5 mm, such as about10 mm. In alternative embodiments, the width W can be less than 5 mm orgreater than 15 mm. Referring to FIG. 31B, the paddles 606 of the valverepair device 602 are moved outward in the direction Z such that theopening 614 has a width H. The width H can be, for example, betweenabout 10 mm and about 25 mm, such as between about 10 mm and about 20mm, such as between about 12.5 mm and about 17.5 mm, such as about 15mm. In alternative embodiments, the width H can be less than 10 mm ormore than 25 mm. In certain embodiments, the ratio between the width Hand the width W can be about 5 to 1 or less, such as about 4 to 1 orless such as about 3 to 1 or less, such as about 2 to 1 or less, such asabout 1.5 to 1 or less, such as about 1.25 to 1 or less, such as about 1to 1. The valve repair device 602 can be configured such that thepaddles 606 are pivoted outward in the direction X and then movedoutward in the direction Z to create the opening 614 having a width Hbetween the paddles 606 and the gripping members 608. Alternatively, thevalve repair device 602 can be configured such that the paddles aremoved outward in the direction Z and then pivoted outward in thedirection X to create width H between the paddles 606 and grippingmembers 608. In addition, the valve repair device 602 can be configuredsuch that the paddles 606 are pivoted outward in the direction X andmoved outward in the direction Z simultaneously to create the width Hbetween the paddles 606 and the gripping members 608.

FIGS. 32A-32C illustrate a valve repair device 602 in which the paddles606 are pivoted outward in the direction X, and, subsequently, movedoutward in the direction Z to create a wider opening 614. FIG. 32Aillustrates the valve repair device 602 in a closed position, such thatthe paddles 606 are engaging the gripping members 608. Referring to FIG.32B, the paddles 606 are pivoted outward in the direction X to create anopening 614 having a width W for receiving valve tissue. Referring toFIG. 32C, after the paddles 606 are pivoted outward in the direction X,the paddles 606 are moved outward in the direction Z such that theopening 614 has a width H. After valve tissue is received in theopenings 614 between the paddles 606 and the gripping members 608, thevalve repair device is moved back to the closed position (as shown inFIG. 32A) to secure the valve repair device 602 to the valve tissue. Thevalve repair device 602 can include any other features for a valverepair device discussed in the present application, and the valve repairdevice 602 can be positioned to engage valve tissue 820 as part of anysuitable valve repair system (e.g., any valve repair system disclosed inthe present application).

FIGS. 33A-33C illustrate a valve repair device 602 in which the paddles606 are moved outward in the direction Z, and, subsequently, pivotedoutward in the direction X to create a wider opening 614. FIG. 33Aillustrates the valve repair device 602 in a closed position, such thatthe paddles 606 are engaging the gripping members 608. Referring to FIG.33B, the paddles 606 are moved outward in the direction Z to create anopening 614 having a width W for receiving valve tissue. Referring toFIG. 33C, after the paddles 606 are moved outward in the direction Z,the paddles 606 are pivoted outward in the direction X such that theopening 614 has a width H. After valve tissue is received in theopenings 614 between the paddles 606 and the gripping members 608, thevalve repair device is moved back to the closed position (as shown inFIG. 33A) to secure the valve repair device 602 to the valve tissue. Thevalve repair device 602 can include any other features for a valverepair device discussed in the present application, and the valve repairdevice 602 can be positioned to engage valve tissue 820 as part of anysuitable valve repair system (e.g., any valve repair system disclosed inthe present application).

While FIGS. 32A-32C illustrate a valve repair device 602 in which thepaddles 606 are pivoted and then spread apart, and FIGS. 33A-33Cillustrate a valve repair device 602 in which the paddles 606 are spreadapart and then pivoted, it alternative embodiments, a valve repairdevice 602 can include paddles 606 that can be spread apart and pivotedsimultaneously. In addition, in certain embodiments, the paddles 606 canbe spread apart and pivoted independently of each other. That is, in theembodiments for the valve repair device 602 shown in FIGS. 32A-32C and33A-33C, as well as the embodiment in which the spreading apart andpivoting of each paddle 606 is completed simultaneously, the paddles 606can be controlled independently of each other.

Referring to FIGS. 34A-34B, another exemplary embodiment of a valverepair device 602 configured to close a wide gap 3002 (FIG. 30) betweenthe anterior leaflet 3003 and the posterior leaflet 3004 includes aW-shaped mechanism. In particular, the valve repair device 602 includesa coupler 605 configured to move along a shaft 603 and paddles 606pivotally attached to the coupler 605. The paddles 606 include an innerlink 3402 and an outer link 3404. The inner link 3402 of each paddle 606is pivotally attached to coupler 605, and the outer link 3404 of eachpaddle 606 is pivotally attached to the corresponding inner link 3402.Referring to FIG. 34A, the valve repair device 602 is shown in a closedposition. Referring to FIG. 34B, movement of the coupler 605 in thedirection Y causes the inner links 3402 of the paddles 606 to extend inan outward direction X. In the illustrated example, the inner links 3402engage a cam member 3403, which forces the inner links 3402 to open inthe X direction. Although the illustrated embodiment shows a valverepair device 602 having generally linear links 3402, 3404 that create aW-shaped mechanism, it should be understood that the links 3402, 3404may take any suitable form that allows the valve repair device 602 tofunction as shown in FIGS. 34A-34B. In embodiments in which the links3402, 3404 take non-linear forms (e.g., a curved form), the valve repairdevice may not have a W-shaped mechanism, however, the valve repairdevice can include similar connections such that the valve repair devicewill function as shown in FIGS. 34A-34B.

The outer links 3404 can be moved to the illustrated more open positionin the direction Z in a variety of different ways. For example, theouter links cam be moved using any of the clasp control arrangementsdescribed herein. For example, movement of the outer links 3404 can becontrolled using any of the clasp control arrangements shown in FIGS.22-26 and/or any of the paddle control arrangements described herein. Inone embodiment, referring to FIGS. 34C-34D, a link 3411 is attached tothe pivotal connection between the inner link 3402 and the coupler 605and the pivotal connection between the inner link 3402 and the outerlink 3404, such that movement of the coupler 605 in the direction Ycauses a first end 3413 of the link 3411 to rotate in the direction Mwith the pivotal connection 3475, which causes a second end 3415 of thelink 3411 to rotate in the direction N with the pivotal connection 3477.The rotation of the second end 3415 of the link 3411 in the direction Ncauses the outer link 3404 to move to an open position in the directionZ.

For illustrative purposes, the embodiment shown in FIGS. 34C-34D show alink 3411 for one of the paddles 606, however, it should be understoodthat another link 3411 interacts with the other paddle in the samemanner described above to cause the outer link 3404 of the other paddleto move to an open position in the direction Z. In an alternativeembodiment, a four-bar linkage can be used to move the paddles 606 to anopen position. In another alternative embodiment, a suture can beremovably attached to the outer links 3404 of the paddles 606, and thesuture can be controlled to move the outer links 3404 of the paddles 606to an open position in the direction Z.

In certain embodiments, the valve repair device 602 includes a biasingmember 3410 (e.g., a spring) that attaches the inner links 3402 of thepaddles 606 to each other. The biasing member 3410 maintains the innerlinks 3402 in a closed position (as shown in FIGS. 34A and 34C), untilthe inner links 3402 engage the cam member 3403 (as shown in FIGS. 34Band 34D). The valve repair device 602 can include any other features fora valve repair device discussed in the present application, and thevalve repair device 602 can be positioned to engage valve tissue 820 aspart of any suitable valve repair system (e.g., any valve repair systemdisclosed in the present application).

Referring to FIGS. 35A-35B, another exemplary embodiment of a valverepair device 602 configured to close a wide gap 3002 (FIG. 30) betweenthe anterior leaflet 3003 and the posterior leaflet 3004 includes aW-shaped mechanism. In particular, the valve repair device 602 includesa coupler 605 configured to be moved along a shaft 603 and paddles 606pivotally attached to the shaft and to the coupler 605. The lower ends3501 of each paddle 606 of the valve repair device 602 are pivotallyconnected to the shaft at point A. Each of the paddles 606 include anintermediate member 3502 that pivotally attach the paddles to thecoupler 605 at pivot point B. Referring to FIG. 35A, the valve repairdevice 602 is shown in a closed position. Referring to FIG. 35B,movement of the coupler 605 in the direction Y causes the intermediatemembers 3502 of the paddles 606 to pivot such that a lower end 3503 ofthe intermediate members 3502 extend in an outward direction X, whichcauses the paddles 606 to move to an open position in the direction Z.The valve repair device 602 can include any other features for a valverepair device discussed in the present application, and the valve repairdevice 602 can be positioned to engage valve tissue 820 as part of anysuitable valve repair system (e.g., any valve repair system disclosed inthe present application).

Referring to FIGS. 36A-36B, another exemplary embodiment of a valverepair device 602 configured to close a wide gap 3002 (FIG. 30) betweenthe anterior leaflet 3003 and the posterior leaflet 3004 includes aW-shaped mechanism. In particular, the valve repair device 602 includespaddles 606 having a linkage 3602 pivotally attaching the paddles 606 toa shaft 603 of the valve repair device 602. The linkage 3602 includes aninner link 3603 and an outer link 3605. The inner link 3603 is pivotallyattached to the shaft 603 and pivotally attached to the outer link 3605.The outer link 3605 is pivotally attached to the inner link 3603 andpivotally attached to the paddle 606. The paddles 606 are also attachedto a link 3608 of the valve repair device 602. A paddle controlmechanism 610 is configured to move the pivotal connection at point Abetween the inner link 3603 and the outer link 3605 of the linkage 3602in the direction Y, which causes the paddles 606 to move between an openposition (as shown in FIG. 36B) and a closed position (as shown in FIG.36A).

Still referring to FIGS. 36A and 36B, although the paddle controlmechanism is shown attached at the pivotal connection point A, it shouldbe understood that the paddle control mechanism 610 can be attached toone or more of any of the links of the valve repair device 602. Forexample, the paddle control mechanism 610 can be coupled to the paddle606, the link 3605, and/or the link 3603. The paddle control mechanism610 can take any suitable form, such as, for example, a control wire orany other form described in the present application. For example, thepaddle control device 610 can take the form of any of the grippercontrol devices shown in FIGS. 6-8 and 22-26. The valve repair device602 can include any other features for a valve repair device discussedin the present application.

Referring to FIG. 36C, the paddle control mechanism 610 of theembodiment illustrated by FIGS. 36A and 36B can include a spool 3620 anda line 3622 (e.g., a suture, a wire, etc.), and the line is attached toand wrapped around the spool. In this embodiment, creating a force onthe line 3622 in the direction Z causes the spool 3620 to turn and line3622 to be unwrapped from the spool. In this embodiment, the rotation ofthe spool 3620 causes the paddle control mechanism 610 to move in thedirection Y and the valve repair device 602 to move to the open position(as shown in FIG. 36B).

Referring to FIGS. 36D-36E, another exemplary embodiment of a valverepair device 602 configured to close a wide gap 3002 (FIG. 30) betweenthe anterior leaflet 3003 and the posterior leaflet 3004 includes asemi-rigid W-shaped mechanism. In particular, the valve repair device602 has a linkage 3602 that flexibly attaches the paddles 606 to a shaft603 of the valve repair device 602. The linkage 3602 includes a rigidinner link 3603 and an outer rigid link 3605. The inner rigid link 3603is flexibly attached to the shaft 603 by a flexible member or portion3613 and flexibly attached to the outer rigid link 3605 by a flexiblemember or portion 3611, and the outer rigid link 3506 is flexiblyattached to the paddle 606 by a flexible member or portion 3615. Thepaddles 606 are also flexibly attached to a link 3608 of the valverepair device 602 by a flexible member or portion 3617. The rigid links3603, 3605 can be made of, for example, steel or nitinol. The flexiblemembers 3611, 3613, 3615, 3617 can be made of, for example, nitinol. Apaddle control mechanism 610 is configured to move the pivotalconnection at point A between the inner link 3603 and the outer link3605 of the linkage 3602 in the direction Y, which causes the paddles606 to move between an open position (as shown in FIG. 36D) and a closedposition (as shown in FIG. 36C). However, the paddle control mechanism610 can be attached to one or more of any of the links of the valverepair device. For example, the paddle control mechanism 610 can becoupled to the paddle 606, the link 3605, and/or the link 3603. Thepaddle control mechanism 610 can take any suitable form, such as, forexample, a control wire or any other form described in the presentapplication. For example, the paddle control device 610 can take theform of any of the gripper control devices shown in FIGS. 6-8 and 22-26.The valve repair device 602 can include any other features for a valverepair device discussed in the present application.

Referring to FIGS. 37A-37D, another exemplary embodiment of a valverepair device 602 configured to close a wide gap 3002 (FIG. 30) betweenthe anterior leaflet 3003 and the posterior leaflet 3004 includes wiremesh paddles 606 and an internal cam 3702 configured to push the meshpaddles 606 apart. The internal cam 3702 is rotatably attached to theshaft 603 such that the cam can be moved between a first position (asshown in FIGS. 37A-37B) and a second position (as shown in FIGS.37C-37D). FIG. 37B is a top view illustrating the internal cam 3702 inthe first position, shown along the lines B-B in FIG. 37A. FIG. 37D is atop view illustrating the internal cam 3702 in the second position,shown along the lines D-D in FIG. 37C.

Referring to FIGS. 37A and 37B, when the internal cam 3702 is in thefirst position, the internal cam does not engage the paddles 606, andthe valve repair device is maintained in a closed position. Referring toFIGS. 37C and 37D, when the internal cam 3702 is in the second position,the internal cam engages the paddles 606 to move the paddles to move thepaddles in an outward direction X to an open position. The valve repairdevice 602 is moved from the open position to the closed position bymoving the internal cam 3702 from the second position to the firstposition.

In some embodiments, referring to FIGS. 37E-37F, the paddles 606 of thevalve repair device can include a flexible member or portion 3711 thatbias the paddles into the closed position or the open position. Theflexible member or portion 3711 can be configured to flex upon beingengaged by the cam 3702 to allow the paddles 606 to move to the openposition. The flexible member or portion 3711 is also configured towiden the reach of the paddles 606 when the paddles are in the openposition. Any other suitable mechanisms can be used to bias the paddlesin the closed position and/or widen the reach of the paddles 606 whenthe paddles are in the open position, such as, for example, aspring-loaded mechanism. The valve repair device 602 can include anyother features for a valve repair device discussed in the presentapplication, and the valve repair device 602 can be positioned to engagevalve tissue 820 as part of any suitable valve repair system (e.g., anyvalve repair system disclosed in the present application). The meshpaddles 606 can be made out of any suitable material that can beexpanded by the internal cam 3702, such as, for example, nitinol,stainless steel, or any braided or electrospun material.

Referring to FIGS. 38-39, in certain situations, the mitral valve 3001of a patient can have a wide gap 3002 between the anterior leaflet 3003and the posterior leaflet 3004 when the mitral valve is in a closedposition (i.e., during the systolic phase). For example, the gap 3002can have a width W between about 2.5 mm and about 17.5 mm, such asbetween about 5 mm and about 15 mm, such as between about 7.5 mm andabout 12.5 mm, such as about 10 mm. In some situations, the gap 3002 canhave a width W greater than 15 mm. In any of the above-mentionedsituations, a valve repair device is desired that fills a sufficientvolume to allow the gap 3002 to be closed or filled without placing alarge amount of strain on the leaflets 3003, 3004. For example, thevalve repair device can include a coaptation or spacer element 3800.

Referring to FIG. 39, in certain embodiments, the coaptation or spacerelement 3800 is attached to the valve repair device 602, such that, whenthe paddles 606 and gripping members 608 secure the valve repair device602 to the mitral valve 3001, the coaptation or spacer element 3800 isdisposed in the gap 3002 between the anterior leaflet 3003 and theposterior leaflet 3004. The coaptation or spacer element 3800 can bemade of any suitable material, such as, for example, braided mesh,fabric, biocompatible material, foam, pericardial tissue, any materialdisclosed herein, etc.

Referring to FIGS. 40A-40B, an exemplary embodiment of a valve repairdevice 602 has a coaptation or spacer element 3800 attached to the shaft603 of the valve repair device. The spacer element 3800 can extend pastthe outer edges 4001 of the gripping members 3800 as illustrated forproviding additional surface area for closing the gap 3002 (FIGS. 38-39)of a mitral valve 301. In an alternative embodiment, the coupler member605 can take the form of the spacer element 3800. That is, a singleelement can be used as the coupler member 605 that causes the paddles606 to move between the open and closed positions and the coaptation orspacer element 3800 that closes the gap between the leaflets 3003, 3004when the valve repair device 602 is attached to the leaflets. The valverepair device 602 can include any other features for a valve repairdevice discussed in the present application, and the valve repair device602 can be positioned to engage valve tissue 820 as part of any suitablevalve repair system (e.g., any valve repair system disclosed in thepresent application).

Referring to FIGS. 42A-42C, the coaptation or spacer element 3800 shownin FIGS. 40A-40B can take a variety of different shapes. Referring toFIG. 42A, an exemplary embodiment of a spacer element 3800 includes amain body 4210 a extending between the gripping members 608 and past theedges 4201 of the gripping members, and extended portions 4212 a thatextend from the main body 4210 a. The extended portions 4212 a allowportions of the gap 3002 (FIGS. 38-39) of the mitral valve between theanterior leaflet 3003 and posterior leaflet 3004 and adjacent to thevalve repair device 602 to be filled when the valve repair device is ina closed position. That is, when a valve repair device 602 is attachedto a mitral valve to prevent regurgitation of blood through the mitralvalve, the portions of the mitral valve next to the valve repair devicemay include openings from the tissue of the mitral valve extendingaround the valve repair device. The extended portions 4212 a areconfigured to fill or plug the openings adjacent to the valve repairdevice 602. In the illustrated embodiment, the length L of the extendedportions 4212 a are greater than the width W of the extended portions.

Referring to FIG. 42B, another exemplary embodiment of a coaptation orspacer element 3800 includes a main body 4210 b extending between thegripping members 608 and extended portions 4212 b that extend from themain body 4210 b. In the illustrated embodiment, the extended portions4212 b have a semicircular shape. The extended portions 4212 b areconfigured to fill the openings adjacent to the valve repair device 602due to tissue of the mitral valve extending around the valve repairdevice.

Referring to FIG. 42C, another exemplary embodiment of a spacer element3800 includes a main base assembly 4210 c extending between the grippingmembers 608, first extending portions 4212 c that extend from the mainbody 4210 c, and second extending portions 4214 c that extend from thefirst extending portions 4212 c. In the illustrated embodiment, thefirst extended portions 4212 c have a semicircular shape, and the secondextended portions 4214 c have a length L that is greater than its widthW. The extended portions 4212 b are configured to fill the openingsadjacent to the valve repair device 602 due to tissue of the mitralvalve extending around the valve repair device.

Referring to FIGS. 41A-41D, another exemplary embodiment of a valverepair device 602 has a coaptation or spacer element 3800 attached tothe gripping members 608 a, 608 b of the valve repair device. The spacerelement 3800 includes a first portion 4102 attached to one grippingmember 608 a and a second portion 4104 attached to the other grippingmember 608 b. Referring to FIG. 41C, the valve repair device 602 isshown in the closed position. When the valve repair device 602 is in theclosed position, the first portion 4102 of the spacer element 3800 andthe second portion 4104 of the spacer element 3800 engage each other andsurround the shaft 603 (as shown in FIG. 41B). Referring to FIG. 41D,the valve repair device 602 is shown in the open position, the firstportion 4102 of the spacer element 3800 moves with the gripping member608 a, and the second portion 4104 of the spacer element 3800 moves withthe gripping member 608 b. A coaptation or spacer element 3800 havingmultiple portions 4102, 4104 allows the gripping members 608 a, 608 b tobe moved to adjust the width of the opening between the paddles 606 andthe gripping members, which is advantageous in attaching the valverepair device 602 to valve tissue 820. Referring to FIG. 41B, the spacerelement 3800 extends past the outer edges 4001 of the gripping members3800 for providing additional surface area for filling the gap 3002(FIGS. 38-39) of a mitral valve 301. The valve repair device 602 caninclude any other features for a valve repair device discussed in thepresent application, and the valve repair device 602 can be positionedto engage valve tissue 820 as part of any suitable valve repair system(e.g., any valve repair system disclosed in the present application).

Referring to FIGS. 43A-43C, the coaptation or spacer element 3800 shownin FIGS. 41A-41D can take a variety of different shapes. Referring toFIG. 43A, an exemplary embodiment of a spacer element 3800 in the closedposition includes a main body 4310 a extending between the grippingmembers 608 and past the edges 4201 of the gripping members, andextended portions 4312 a that extend from the main body 4310 a. Theextended portions 4312 a allow portions of the gap 3002 (FIGS. 38-39) ofthe mitral valve between the anterior leaflet 3003 and posterior leaflet3004 and adjacent to the valve repair device 602 to be filled when thevalve repair device is in a closed position. That is, when a valverepair device 602 is attached to a mitral valve to prevent regurgitationof blood through the mitral valve, the portions of the mitral valve nextto the valve repair device may include openings from the tissue of themitral valve extending around the valve repair device. The extendedportions 4312 a are configured to fill the openings adjacent to thevalve repair device 602. In the illustrated embodiment, the length L ofthe extended portions 4312 a are greater than the width W of theextended portions.

Referring to FIG. 43B, another exemplary embodiment of a coaptation orspacer element 3800 in the closed position includes a main body 4310 bextending between the gripping members 608 and extended portions 4312 bthat extend from the main body 4310 b. In the illustrated embodiment,the extended portions 4312 b have a semicircular shape. The extendedportions 4312 b are configured to fill the openings adjacent to thevalve repair device 602 due to tissue of the mitral valve extendingaround the valve repair device.

Referring to FIG. 43C, another exemplary embodiment of a coaptation orspacer element 3800 includes a main base assembly 4310 c extendingbetween the gripping members 608, first extending portions 4312 c thatextend from the main body 4310 c, and second extending portions 4314 cthat extend from the first extending portions 4312 c. In the illustratedembodiment, the first extended portions 4312 c have a semicircularshape, and the second extended portions 4314 c have a length L that isgreater than its width W. The extended portions 4312 b are configured tofill the openings adjacent to the valve repair device 602 due to tissueof the mitral valve extending around the valve repair device.

Referring to FIGS. 44A-44B, in certain embodiments, an expandingcoaptation or spacer element 3800 is integral with the valve repairdevice 602. The expanding spacer element 3800 is configured to expand asthe paddles 606 close (as shown in FIG. 44B). Referring to FIG. 44A, thevalve repair device 602 is in an open position such that valve tissuecan be received in the opening 614 between the expanding spacer element3800 and the paddles 606. Referring to FIG. 44B, the valve repair device602 is in the closed position, in which the paddles 606 and the expandedspacer element 3800 are engaged to secure the valve repair device tovalve tissue. When the spacer elements 3800 and the paddles 606 areengaged, the spacer element 3800 expands to provide a larger surfacearea for closing a gap 3002 (FIG. 38) between the anterior leaflet 3003and posterior leaflet 3004 of a mitral valve 3001. In the illustratedembodiment, the valve repair device 602 takes the form of the valverepair device 602 in FIGS. 35A-35B. However, any valve repair device 602described in the present application can include an expanding spacerelement 3800. The valve repair device 602 can include any other featuresfor a valve repair device discussed in the present application, and thevalve repair device 602 can be positioned to engage valve tissue 820 aspart of any suitable valve repair system (e.g., any valve repair systemdisclosed in the present application).

Referring to FIGS. 45A-46D, in certain situations, the valve repairdevice 602 needs to be detached from a native valve and removed from thepatient. In these situations, it is advantageous to have a valve repairdevice that can be narrowed and rearranged (to a bailout position) suchthat the valve repair device will be easier to remove from the patientwithout disturbing any valve tissue of the patient's heart. Referring toFIGS. 45A-45C, the base assembly 604 of an exemplary embodiment of avalve repair device 602 includes a first link 4521 extending from pointA to point B, a second link 4522 extending from point A to point C, athird link 4523 extending from point B to point D, a fourth link 4524extending from point C to point E, and a fifth link 4525 extending frompoint D to point E. A coupler 605 is movably attached to a shaft 603,and the shaft 603 is fixed to the fifth link 4525. The first link 4521and the second link 4522 are pivotally attached to the coupler 605 atpoint A, such that movement of the coupler 605 along the shaft 603 movesthe location of point A and, consequently, moves the first link 4521 andthe second link 4522. The first link 4521 and the third link 4523 arepivotally attached to each other at point B, and the second link 4522and the fourth link 4524 are pivotally attached to each other at pointC. One paddle 606 a is attached to first link 4521 such that movement offirst link 4521 causes the paddle 606 a to move, and the other paddle606 b is attached to the second link 4522 such that movement of thesecond link 4522 causes the paddle 606 b to move.

In order to move the valve repair device 602 from the closed position(as shown in FIG. 45A) to the bailout position (as shown in FIG. 45C),the coupler 605 is moved along the shaft 603 in the direction Y, whichmoves the pivot point A for the first link 4521 and the second link 4522to a new position. Referring to FIG. 45A, the valve repair device 602 isshown in a closed position with an angle α between the paddle 606 andthe shaft 603. The angle α can be, for example, between about 0 degreesand about 45 degrees, such as between about 5 degrees and about 40degrees, such as between about 15 degrees and about 30 degrees, such asbetween about 20 degrees and about 25 degrees. Referring to FIG. 45B,the valve repair device 602 is moved to the open position by moving thecoupler 605 along the shaft 603 in the direction Y. Movement of thecoupler 605 in the direction Y causes the first link 4521 to pivot aboutpoint A such that the first link 4521 and the second link 4522 moveoutward in the direction Z, which causes the paddles 606 a, 606 b tomove downward and outward in the direction H. Referring to FIG. 45C, thevalve repair device 602 is moved to the bailout position by continuingto move the coupler 605 along the shaft 603 in the direction Y. Thecontinued movement of the coupler 605 in the direction Y causes thefirst link 4521 and the second link 4522 to move inward in the directionM, which causes the paddles 606 a, 606 b to move downward and inward inthe direction N. Still referring to FIG. 45C, in the bailout position,the valve repair device 602 has an angle β between the paddles 606 andthe shaft 603. The angle β can be, for example, greater than or equal to120 degrees, such as greater than or equal to 130 degrees, such asgreater than or equal to 140 degrees, such as greater than or equal to150 degrees, such as greater than or equal to 160 degrees.

Referring to FIGS. 46A-46D, the base assembly 604 of another exemplaryembodiment of a valve repair device 602 includes a first link 4621extending from point A to point B, a second link 4622 extending frompoint A to point C, a third link 4623 extending from point B to point D,a fourth link 4624 extending from point C to point E, a fifth link 4625extending from point D to point F, and a sixth link 4626 extending frompoint E to point F. A coupler 605 is movably attached to a shaft 603,and the shaft 603 is attached to the fifth link 4625 and the sixth link4626 at point F. The first link 4621 and the second link 4622 arepivotally attached to the coupler 605 at point A, such that movement ofthe coupler 605 along the shaft 603 moves the location of point A and,consequently, moves the first link 4621 and the second link 4622. Thefifth link 4625 and the sixth link 4626 are pivotally attached to theshaft at point F, such that movement of the shaft moves the location ofpoint F and, consequently, moves the fifth link 4625 and the sixth link4626. A locking element 4631 is configured to selectively lock the fifthlink 4625 and the sixth link 4626 to the shaft at point F, such that thefifth link 4625 and the sixth link 4626 cannot pivot relative to theshaft 603 when the locking element 4631 is in the locked position.However, when the locking element 4631 is in the unlocked position, thefifth link 4625 and the sixth link 4626 can pivot about the shaft 603when the shaft moves the location of point F (as described above). Thefirst link 4621 and the third link 4623 are pivotally attached to eachother at point B, and the second link 4622 and the fourth link 4624 arepivotally attached to each other at point C. One paddle 606 a isattached to first link 4621 such that movement of first link 4621 causesthe paddle 606 a to move, and the other paddle 606 b is attached to thesecond link 4622 such that movement of the second link 4622 causes thepaddle 606 b to move.

In order to move the valve repair device 602 from the closed position(as shown in FIG. 46A) to a bailout position (as shown in FIG. 46C), thelocking element 4631 is maintained in a locked position, and the coupler605 is moved along the shaft 603 in the direction Y, which moves thepivot point A for the first link 4621 and the second link 4622 to a newposition. In order to move the valve repair device 602 from the bailoutposition to the collapsed bailout position (as shown in FIG. 46D), thelocking element 4631 is moved to an unlocked position, and the shaft 603is moved in the direction D, which moves the pivot point F for the fifthlink 4625 and the sixth link 4626 to a new position, which causes thefifth link 4625 and the sixth link 4626 to pivot about the shaft 603.

Referring to FIG. 46A, the valve repair device 602 is shown in a closedposition with an angle α between the paddle 606 and the shaft 603. Theangle α can be, for example, between about 0 degrees and about 45degrees, such as between about 5 degrees and about 40 degrees, such asbetween about 15 degrees and about 30 degrees, such as between about 20degrees and about 25 degrees. Referring to FIG. 46B, the valve repairdevice 602 is moved to the open position by moving the coupler 605 alongthe shaft 603 in the direction Y. Movement of the coupler 605 in thedirection Y causes the first link 4621 and the second link 4622 to moveoutward in the direction Z, which causes the paddles 606 a, 606 b tomove downward and outward in the direction H. The locking element 4631is maintained in the locked position when the valve repair device 602 ismoved from the closed position (as shown in FIG. 46A) to the openposition (as shown in FIG. 46B).

Referring to FIG. 46C, the valve repair device 602 is moved to thebailout position by continuing to move the coupler 605 along the shaft603 in the direction Y. The continued movement of the coupler 605 in thedirection Y causes the first link 4621 and the second link 4622 to moveinward in the direction M, which causes the paddles 606 a, 606 b to movedownward and inward in the direction N. Still referring to FIG. 45C, inthe bailout position, the valve repair device 602 has an angle β betweenthe paddles 606 and the shaft 603. The angle β can be, for example,greater than or equal to 120 degrees, such as greater than or equal to130 degrees, such as greater than or equal to 140 degrees, such asgreater than or equal to 150 degrees, such as greater than or equal to160 degrees. The locking element 4631 is maintained in the lockedposition when the valve repair device 602 is moved from the openposition (as shown in FIG. 46B) to the bailout position (as shown inFIG. 46C).

Referring to FIG. 46D, the valve repair device 602 is moved from thebailout position to the collapsed position by moving the locking element4631 to an unlocked position and moving the shaft 603 in the directionD, which causes the fifth link 4625 and the sixth link 4626 to pivotabout connection point F and move upward in a direction J, which causesthe third link 4623 and the fourth link 4624 to move inward and downwardin the direction Q, which causes the paddles 606 a, 606 b to movedownward and inward in the direction Q. Still referring to FIG. 46D, inthe collapsed bailout position, the valve repair device 602 has an angleμ between the paddles 606 and the shaft 603. The angle μ can be, forexample, greater than or equal to 120 degrees, such as greater than orequal to 130 degrees, such as greater than or equal to 140 degrees, suchas greater than or equal to 150 degrees, such as greater than or equalto 160 degrees, such as greater than or equal to 170 degrees.

It is advantageous to have a valve repair device that includes featuresto ensure that the valve repair device remains in a closed positionafter the valve repair device is attached to the native valve of apatient. In other words, it is advantageous to have a valve repairdevice that includes features to prevent the valve repair device frombecoming detached from the native valve of a patient after placement ofthe valve repair device inside of the patient, which could causeproblems (e.g., regurgitation of blood through the mitral valve).Examples of additional features for preventing a valve repair devicefrom becoming detached from a native valve are shown in FIGS. 47A-49.

Referring to FIGS. 47A-47B, an exemplary embodiment of a valve repairdevice 602 includes a latch member 4701 attached to the paddles 606, inwhich the latch member 4701 is configured to attach the paddles 606 tothe gripping members 608 when the valve repair device is in the closedposition. The valve repair device 602 can include any other features fora valve repair device discussed in the present application, and thevalve repair device 602 can be positioned to engage valve tissue 820 aspart of any suitable valve repair system (e.g., any valve repair systemdisclosed in the present application). In the illustrated embodiment,the valve repair device 602 includes an optional lock 607 configured tokeep a coupler 605 in a locked condition on the shaft 603. If theoptional lock 607 fails, however, the coupler 605 could move on theshaft 603 and cause the valve repair device to move to an open position.The latch member 4701 is configured to keep the valve repair device 602in the closed position if the lock 607 fails.

Referring to FIG. 47A, the valve repair device 602 is in an openposition with valve tissue 820 disposed in the opening 614 between thepaddles 606 and the gripping members 608. Referring to FIG. 47B, thevalve repair device 602 is moved to the closed position such that thevalve tissue 820 is secured between the paddles 606 and the grippingmembers 608 of the valve repair device. The valve repair device 602 canbe moved to the closed position by any suitable manner, such as, forexample, any manner described in the present application. When the valverepair device 602 is moved to the closed position, the latch member 4701punctures the valve tissue 820 and the gripping member 608 to secure thepaddle to the gripping member. The latch member 4701 can take anysuitable form that is capable of securing the paddles 606 to thegripping members 608, such as, for example, metals, plastics, etc.

Referring to FIG. 48, another exemplary embodiment of a valve repairsystem 600 includes a delivery device 601 and a valve repair device 602,in which is delivery device is configured to deliver the valve repairdevice to the native valve of a patient, and in which the valve repairdevice is configured to attach to leaflets of a native valve to repairthe native valve of the patient. The delivery device 601 can take anysuitable form that is capable of delivering the valve repair device 602to the native valve of a patient, such as, for example, any formdescribed in the present application. The valve repair device 602includes a base assembly 604, a pair of paddles 606, and a pair ofgripping members 608. The base assembly 604 of the valve repair device602 has a shaft 603 and a coupler 605 configured to move along theshaft. The coupler 605 is mechanically connected to the paddles suchthat movement of the coupler along the shaft 603 causes the paddles tomove between an open position and a closed position. In the closedposition, the paddles 606 and the gripping members 608 engage valvetissue and each other to secure the valve repair device 602 to the valvetissue. The valve repair device 602 also includes a biasing member 4807(e.g., a spring) configured to bias the coupler 605 on the shaft suchthat the valve repair device 602 is in a closed position.

In certain embodiments, the valve repair system 600 includes a placementshaft 613 that is removably attached to the shaft 603 of the baseassembly 604 of the valve repair device 602. After the valve repairdevice 602 is secured to valve tissue, the placement shaft 613 isremoved from the shaft 603 to remove the valve repair device 602 fromthe valve repair system 600, such that the valve repair device 602 canremain attached to the valve tissue, and the delivery device 601 can beremoved from a patient's body. After the valve repair device 602 isattached to the valve tissue, and the valve repair system 600 is removedfrom the patient's body, the biasing member 4807 maintains the valverepair device in a closed position to prevent detachment of the valverepair device from the valve tissue. The valve repair device 602 caninclude any other features for a valve repair device discussed in thepresent application, and the valve repair device 602 can be positionedto engage valve tissue 820 as part of any suitable valve repair system(e.g., any valve repair system disclosed in the present application).

Referring to FIG. 49, another exemplary embodiment of a valve repairsystem 600 includes a delivery device 601 and a valve repair device 602,in which the delivery device is configured to deliver the valve repairdevice to the native valve of a patient, and in which the valve repairdevice is configured to attach to leaflets of a native valve to repairthe native valve of the patient. The delivery device 601 can take anysuitable form that is capable of delivering the valve repair device 602to the native valve of a patient, such as, for example, any formdescribed in the present application. The valve repair device 602includes a base assembly 604, a pair of paddles 606, and a pair ofgripping members 608. The base assembly 604 of the valve repair device602 has a shaft 603 and a coupler 605 configured to move along theshaft. In the illustrated embodiment, the shaft 603 includes a threadedportion 4902, and the coupler 605 is configured to move along thethreaded portion 4902 of the shaft. That is, rotating the shaft 603causes the coupler 605 to move up and down the shaft 603. The coupler605 is mechanically connected to the paddles such that movement of thecoupler along the shaft 603 causes the paddles to move between an openposition and a closed position. In the closed position, the paddles 606and the gripping members 608 engage valve tissue and each other tosecure the valve repair device 602 to the valve tissue.

In certain embodiments, the valve repair system 600 includes a placementshaft 613 that is removably attached to the shaft 603 of the baseassembly 604 of the valve repair device 602. After the valve repairdevice 602 is secured to valve tissue, the placement shaft 613 isremoved from the shaft 603 to remove the valve repair device 602 fromthe valve repair system 600, such that the valve repair device 602 canremain attached to the valve tissue, and the delivery device 601 can beremoved from a patient's body. After the valve repair device 602 isattached to the valve tissue, and the valve repair system 600 is removedfrom the patient's body, the valve repair device is prevented fromdetaching from the valve tissue, because the coupler can only be movedby rotating the shaft 603. The valve repair device 602 can include anyother features for a valve repair device discussed in the presentapplication, and the valve repair device 602 can be positioned to engagevalve tissue 820 as part of any suitable valve repair system (e.g., anyvalve repair system disclosed in the present application).

Referring to FIGS. 50-54, embodiments of valve repair systems 600include a delivery device 601 and a valve repair device 602, in whichthe delivery device is configured to deliver the valve repair device tothe native valve of a patient, and in which the valve repair device isconfigured to attach to leaflets of a native valve to repair the nativevalve of the patient. The delivery device 601 can take any suitable formthat is capable of delivering the valve repair device 602 to the nativevalve of a patient, such as, for example, any form described in thepresent application. The valve repair device 602 is similar to the valverepair devices described above and includes a base assembly 604, a pairof paddles 606, and a pair of gripping members 608. The base assembly604 of the valve repair device 602 has a shaft 603 and a coupler 605configured to move along the shaft. The coupler 605 is mechanicallyconnected to the paddles such that movement of the coupler along theshaft 603 causes the paddles to move between an open position and aclosed position. In some embodiments, the valve repair device 602includes a lock 607 configured to lock the coupler 605 in a desiredposition on the shaft (as shown in FIGS. 50-53B). In alternativeembodiments, the valve repair device 602 includes a biasing member 4807configured to maintain the coupler 605 in a desired position on theshaft 603 (as shown in FIG. 54). In the closed position, the paddles 606and the gripping members 608 engage valve tissue and each other tosecure the valve repair device 602 to the valve tissue. In certainembodiments, the valve repair system 600 includes a placement shaft 613that is removably attached to the shaft 603 of the base assembly 604 ofthe valve repair device 602. After the valve repair device 602 issecured to valve tissue, the placement shaft 613 is removed from theshaft 603 to remove the valve repair device 602 from the valve repairsystem 600, such that the valve repair device 602 can remain attached tothe valve tissue, and the delivery device 601 can be removed from apatient's body. The valve repair device 602 can include any otherfeatures for a valve repair device discussed in the present application,and the valve repair device 602 can be positioned to engage valve tissue820 as part of any suitable valve repair system (e.g., any valve repairsystem disclosed in the present application).

Referring to FIG. 50, in some embodiments, the gripping members 608 areattached to the paddles 606. In the example illustrated by FIG. 50, thegripping members 608 include an attachment portion 5010, a hinge or flexportion 5012, and a gripping or barbed portion 5014. The attachmentportion 5010 can take any form that allows the gripping member to beattached to the paddle 606. The hinge or flex portion 5012 can take avariety of different forms. For example, the hinge or flex portion canbe configured to bias the gripping or barbed portion 5014 toward theattachment portion 5010. In one exemplary embodiment, the hinge or flexportion 5012 biases the gripping or barbed portion 5014 to a fullyclosed position where the gripping or barbed portion engages theattachment portion 5010 and/or the paddle 606. When valve tissue ispositioned between the paddle 606 and the gripping portion 5014, thehinge or flex portion biases the gripping portion 5014 to clamp thevalve tissue between the gripping or barbed portion 5014 and the paddle.The gripping member 608 illustrated by FIG. 50 moves with the paddle606. The hinge or flex portion 5012 allows the gripping portion 5014 tomove in the direction indicated by arrows 5020 and can allow thegripping portion to be pulled in the direction indicated by arrows 5022.

In certain embodiments, it is advantageous for the barbed portion 609 tobe disposed toward a proximal end of the gripping members 608 because itwill provide for an easier release of the gripping members 608 fromvalve tissue. Referring to FIG. 51, in one embodiment, the grippingmembers 608 comprise a single row of barbs 5102 configured to engage thevalve tissue and the paddles 606 to secure the valve repair device tothe valve tissue. The single row of barbs 5102 makes it easier for thegripping portion 5014 to release from the valve tissue. In analternative embodiment, the gripping members 608 can comprise two ormore rows of barbs 5102 disposed at a proximal end of the grippingmembers 608. In additional embodiments, the barbs 5102 can be disposedat a proximal end of the gripping members 608 in any other suitableconfiguration that provides for an easier release of the grippingmembers 608 from valve tissue.

In some embodiments, as shown in FIGS. 51A-51E, the gripping member 608is configured to place a tensioning force on the valve tissue when thevalve repair device (e.g., any valve repair device 602 described in thepresent application) is attached to the valve tissue. The grippingmember 608 is slidably connected to the paddle 606, such that thegripping member 608 can be moved along the paddle in the direction X.For example, a gripper control mechanism 611 can be used to move thegripping member 608 along the paddle 606 in the direction X, and thegripper control mechanism 611 can also be used to move the grippingmember 608 between the closed position (as shown in FIG. 51A) and theopen position (as shown in FIG. 51B). The gripper control mechanism 611can take any form described in the present application. In certainembodiments, the valve repair device 602 includes an optional biasingmember 5122 (e.g., a spring) configured to maintain the gripping member608 in a desired position along the paddle 606 (e.g., the position shownin FIGS. 51A and 51E). In the illustrated embodiment, the grippingmember 608 includes a single row of barbs 609 at a proximal end of thegripping members (e.g. as shown in the embodiment of the valve repairdevice 602 shown in FIG. 51), however, it should be understood that thefeatures described herein regarding FIGS. 51A-51E can be used with anyof the embodiments of the valve repair device described in the presentapplication.

Referring to FIG. 51A, the gripping member 608 is shown in a firstposition on the paddle 606 and in a closed position. Referring to FIG.51B, the gripping member 608 is shown after it has been moved in thedirection Z to an open position by the gripper control mechanism 611.Referring to FIG. 51C, the gripping member 608 is shown after it hasbeen moved along the paddle 606 in the direction D to a second position.In certain embodiments, the gripping member 608 is moved along thepaddle in the direction D by the gripper control mechanism 611 or aseparate mechanism. In embodiments that include the biasing member 5122,enough force needs to be applied on the gripping member 608 to move thegripping member in the direction D, which will cause the biasing memberto expand and create a tensioning force on the gripping member 608 inthe direction B. While the illustrated embodiment shows the grippingmember 608 being moved to an open position (as shown in FIG. 51B) priorto the gripping member 608 being moved along the paddle 606 in thedirection D to the second position (as shown in FIG. 51C), it should beunderstood that gripping member 608 can be moved in the direction D tothe second position prior to the gripping member 608 being moved in thedirection Z to an open position or the movements can be simultaneous.Referring to FIG. 51D, the gripping member 608 is moved to a closedposition in the direction Y by the gripper control mechanism 611 tosecure the barbed portion 609 of the gripping member 608 to valve tissue(not shown). In the position shown in FIG. 51D, the biasing member 5122is being maintained in an extended position (e.g., as a result of theforce applied to the gripping member 608 by the gripper controlmechanism (or another mechanism) to keep the gripping member in thesecond position), which means the biasing member 5122 is placing atensioning force on the gripping member 608 in the direction B.Referring to FIG. 51E, after the barbed portion 609 of the grippingmember 608 is secured to the valve tissue, the force maintaining thegripping member 608 in the second position is released, which causes thetensioning force applied by the biasing member 5122 to move the grippingmember 608 along the paddle 606 in the direction M. The movement of thegripping member 608 in the direction M causes the barbed portion 609 tocreate a tensioning force on the valve tissue in the direction T. Thistensioning force on the valve tissue allows the valve repair device 602to maintain a secure connection to the valve tissue.

In another embodiment, as shown in FIGS. 51F-51G, the gripping member608 includes a barbed portion 609 and a weakened or flexing portion5103. The barbed portion 609 is disposed on a first side 5111 of theweakened or flexing portion 5103. In the illustrated embodiment, thebarbed portion 609 includes a single row of barbs, but it should beunderstood that any suitable configuration of the barbs can be used,such as, for example, any configuration described in the presentapplication. The weakened portion or flexing 5103 can be, for example, acutout in the gripping member, a different material as compared to theremainder of the gripping member 608, or can take any other suitableform that allows the weakened or flexing portion 5103 to be weakerand/or more flexible than a remained of the gripping member 608.However, in other embodiments, the weaker and flexible portion 5103 isomitted and the link 5107 and line 5105 described below are still ableto flex the barbed portion as illustrated by FIGS. 51F-51H.

Referring to FIGS. 51F-51H, the gripper control mechanism 611 includes aline 5105 (e.g., a suture) and a push/pull link 5107 configured toreceive the line 5105. For example, the push/pull link 5107 can be acatheter, a wire with a loop (as shown FIG. 25A), or any other link thatis capable of receiving the line 5105 and pushing/pulling the grippingmember 608. A first end 5125 of the line 5105 extends from a deliverydevice (e.g., any delivery device 601 described in the presentapplication) and is removably attached to the gripping member 608 on afirst side 5111 of the weakened or flexible portion 5103 at a firstconnection point A. The line 5105 also extends from the connection pointA and is removably attached to the gripping member 608 on a second side5113 of the weakened or flexible portion 5103 at a second connectionpoint B. In addition, the line 5105 extends from the second connectionpoint B and through push/pull link 5107.

Referring to FIG. 51F, the gripping member 608 is shown in an openposition with a valve tissue member 820 disposed in an opening 614between the gripping member 608 and a paddle (not shown). The grippingmember can be moved to the open position by pulling on the line 5105.Referring to FIG. 51G, the link 5107 and line 5105 of the grippercontrol mechanism 611 is used to move the gripping member 608 in thedirection X to the closed position and flex the portion 609 in thedirection Y. The first end 5125 of the line 5105 is pulled in adirection Y, such that the first side 5111 of the gripping member 608pivots or flexes about the weakened portion 5103. This flexing causesthe barbed portion 609 to move in directions U and Y to a flexedposition. Still referring to FIG. 51G, the link 5107 and the line 5105are moved such that the barbed portion 609 pierces the valve tissue 820while the barbed portion is in the flexed position.

Referring to FIG. 51H, the line 5105 is released, which causes the firstend 5111 of the gripping member 608 to pivot about the weakened orflexible portion 5103. This causes the barbed portion 609 to movethrough the valve tissue 820 in a direction D, which causes the barbedportion 609 the valve repair device to create a tensioning force on thevalve tissue 820 in the direction D. After the gripping member 608 issecured to the valve tissue 820 (as shown in FIG. 51H), the link 5107and the line 5105 are removed from the gripping member 608.

Referring to FIG. 52, in various embodiments, the gripping members 608include a stretchable portion 5202 to allow for movement in thedirection 5204. The movement in the direction 5204 allows for cleandisengagement from the valve tissue. In some embodiments, thestretchable portion 5202 is configured to be moved such that the barbs5102 exit the valve tissue in a direction substantially opposite thedirection in which the barbs entered the valve tissue. Alternatively,the gripping members 608 can be otherwise extendable to allow fordisengagement from the valve tissue without tearing the valve tissue.For example, as mentioned above, the hinge portions 5012 can beconfigured to allow the gripping portions 5014 of the gripping members608 to be pulled in the direction 5204.

Referring to FIGS. 53A-53B, in certain embodiments, the gripping members608 are made of flexible material. Referring to FIG. 53A, the valverepair device 602 is shown in a closed position and secured to valvetissue 820. Referring to FIG. 53B, the gripping members 608 are shownbeing moved by the gripper control mechanism 611 to remove the grippingmembers 608 from the valve tissue 820. In particular, movement of thegripper control mechanism 611 in the direction Y causes the grippingmembers 608 to peel back off of the valve tissue in the direction Z. Theflexible material of the gripping members 608 allows for the peelingback of the gripping members 608 when removing the gripping members fromthe valve tissue 820. The peeling back of the gripping members 608 isadvantageous because it helps the gripping members to pull out of thevalve tissue 820 without damaging the valve tissue. In certainembodiments, the flexible gripping members 608 allows for the barbedportion 609 of the gripping members 608 to be removed from valve tissuein a direction substantially opposite the direction in which the barbsentered the valve tissue.

Referring to FIG. 54, in certain embodiments, the gripping members 608are connected to each other by a separate biasing member 5410 (e.g., aspring) that is configured to maintain the gripping members in a desiredposition, such that, when the paddles 606 are in an open position, awidth W exists between the paddles and the gripping members. The width Wcan be adjusted by engaging the gripping members 608 with the grippercontrol mechanism 611. That is, movement of the gripper controlmechanism 611 into the delivery device in the direction Z will cause thebiasing member 5410 to flex and the paddles to move in an inwarddirection X. Disengagement of the gripping members by the grippercontrol mechanism 611 will cause the biasing member 5410 to move thedesired position (as shown in FIG. 54). The gripper control mechanism611 can take any suitable form for controlling the gripping members 608,such as, for example, any form described in the present application. Inaddition, when the paddles 606 are moved to the closed position, thepaddles will engage the gripping members 608, which will cause thebiasing member to flex and the gripping members to move in an inwarddirection X. The paddles 608 can be moved from the open position to theclosed position in any suitable manner, such as, for example, any mannerdescribed in the present application. While the various devicesdescribed in the present application refer to engaging and repairing themitral valve, it should be understood that these devices can be used inrepairing any other native valves (e.g., the tricuspid valve, thepulmonary valve, the aortic valve) or any other portion of the heart. Inaddition, it should be understood that various features of the variousembodiments for the devices described herein can be used in combinationwith each other.

While the foregoing is a complete description of the preferredembodiments of the invention, various alternatives, modifications, andequivalents can be used. Moreover, it will be obvious that certain othermodifications can be practiced within the scope of the appended claims.

The invention claimed is:
 1. A valve repair device for repairing anative valve of a patient, the valve repair device comprising: a baseassembly comprising a plurality of pivoting links and a shaft; a pair ofpaddles attached to the base assembly, wherein movement of a coupleralong the shaft causes the pivoting links to move the paddles between anopen position and a closed position; a pair of gripping members attachedto the base assembly, wherein the paddles and the gripping members areconfigured to attach to valve leaflets of the patient; and at least onespacer element disposed between the pair of gripping members, whereinthe shaft extends through the at least one spacer element and the spacerelement is configured to fill at least a portion of a gap between thevalve leaflets of the patient.
 2. The valve repair device according toclaim 1, wherein: the shaft extends through the coupler to movablyattach the coupler to the shaft such that the coupler can be moved alongthe shaft; the pair of paddles are pivotally attached to the coupler;and movement of the coupler in a first direction along the shaft causesthe pair of paddles to move to the closed position, and movement of thecoupler in a second direction causes the pair of paddles to move to theopen position.
 3. The valve repair device according to claim 2, whereinthe spacer element is attached to the shaft of the base assembly.
 4. Thevalve repair device according to claim 1, wherein the spacer elementextends past one or more side edges of the gripping members.
 5. Thevalve repair device according to claim 1, wherein the spacer elementcomprises a main portion extending between the gripping members andextending portions that extend past the side edges of the grippingmembers.
 6. The valve repair device according to claim 5, wherein theextending portions have a semi-circular shape.
 7. The valve repairdevice according to claim 1, wherein the spacer element is configured toexpand.
 8. The valve repair device according to claim 1, wherein thespacer element is coupled to the pair of paddles such that movement ofthe paddles from the open position to the closed position causes thespacer to expand.
 9. A valve repair system for repairing a native valveof a patient during a non-open heart procedure, the valve repair systemcomprising: a delivery device having at least one lumen; a valve repairdevice configured to be delivered through the lumen of the deliverydevice, and configured to attach to a native valve of a patient, thevalve repair device comprising: a base assembly comprising a pluralityof pivoting links and a shaft; a pair of paddles attached to the baseassembly, wherein movement of a coupler along the shaft causes thepivoting links to move the paddles between an open position and a closedposition; a pair of gripping members attached to the base assembly,wherein the paddles and the gripping members are configured to attach tovalve leaflets of the patient; at least one spacer element disposedbetween the pair of gripping members, wherein the shaft extends throughthe at least one spacer element and the spacer element is configured tofill at least a portion of a gap between the valve leaflets of thepatient.
 10. The valve repair system according to claim 9, wherein: theshaft extends through the coupler to movably attach the coupler to theshaft such that the coupler can be moved along the shaft; the pair ofpaddles are pivotally attached to the coupler; and movement of thecoupler in a first direction along the shaft causes the pair of paddlesto move to the closed position, and movement of the coupler in a seconddirection causes the pair of paddles to move to the open position. 11.The valve repair system according to claim 10, wherein the spacerelement is attached to the shaft of the base assembly.
 12. The valverepair system according to claim 9, wherein the spacer element extendspast one or more side edges of the gripping members.
 13. The valverepair system according to claim 9, wherein the spacer element comprisesa main portion extending between the gripping members and extendingportions that extend past the side edges of the gripping members. 14.The valve repair system according to claim 13, wherein the extendingportions have a semi-circular shape.
 15. The valve repair systemaccording to claim 9, wherein the spacer is configured to expand. 16.The valve repair system according to claim 15, wherein the spacer iscoupled to the pair of paddles such that movement of the paddles fromthe open position to the closed position causes the spacer to expand.